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1.
Dev Neurorehabil ; 26(1): 63-70, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35833864

RESUMO

OBJECTIVE: To examine the feasibility of a home-based hybrid Bimanual-Intensive-Therapy combined with modified Constraint-Induced-Movement-Therapy (h-BITmCI) in children with spastic unilateral cerebral palsy (SUCP) with low and very low bimanual functional level. METHODS: A single-group of 10 children aged 5-8 years old, performed the hybrid home Bimanual-Intensive-Therapy (BIT, 80 hours) combined with modified Constraint-Induced-Movement-Therapy (mCIMT, 20 hours): h-BITmCI. Thus, Bimanual Functional Performance (BFP), Quality of Life (QoL) and expectations from families were measured through the Assisting Hand Assessment, (AHA), Pediatric Quality of Life Inventory, for Cerebral Palsy, (PedsQLTM v. 3.0, CP) and a specific questionnaire for families for baseline period (week 0), during the treatment phase (week 4 and week 8) and after the intervention (week 10). Repeated measures ANOVA analysis (with post hoc test correction) was used for the BFP and QoL, with a confidence interval (CI) of 95% and with p value <.008 considered statistically significant. RESULTS: Ten children completed the study with an average of 77-hours-BIT and 17-hours-mCIMT. None of the participants dropped out of the study during the follow-up process, and the parents' expectations were fulfilled, indicating high caregiver compliance. During the first 80 hours of BIT, a mean increase of 3.7 AHA units was obtained for the BFP (p = 1.00) and 1.64 points in the QoL (p = 1.00). Clinically relevant changes were observed in the last two weeks (20 hours mCIMT) with a mean increase of 10.6 AHA units in BFP and 6.29 points in QoL (p < .001). CONCLUSIONS: h-BITmCI protocol is feasible to be performed at home with the family's involvement, obtaining the greatest improvements after 100 hours of both therapies. Thus, mCIMT would be a relevant condition to increase the affected upper limb functionality, rather than the dosage used to obtain clinically relevant changes.


Assuntos
Paralisia Cerebral , Qualidade de Vida , Criança , Humanos , Pré-Escolar , Estudos de Viabilidade , Resultado do Tratamento , Modalidades de Fisioterapia , Extremidade Superior
2.
Artigo em Inglês | MEDLINE | ID: mdl-35162500

RESUMO

BACKGROUND: Women with spinal cord injuries usually suffer from sexual dysfunction, such as alterations during arousal and an increase in the time to reach orgasm. However, little evidence has been found on its physiotherapeutic approach, as well as poor adherence to the latter. The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation. METHODS: This is a randomized clinical trial that will recruit 54 women who, one year after a spinal cord injury, suffer from sexual dysfunction associated with the latter. The participants will be randomized to three groups: (a) intervention group 1 treated with transcutaneous tibial nerve electrostimulation (n = 18), (b) intervention group 2 treated with genital vibration (n = 18), and (c) a control group (n = 18). The treatment time will be 12 weeks. Adherence to the treatment will be evaluated, as well as the effectiveness of the treatment, through the Female Sexual Function Index, the Sexual Quality of Life-Female questionnaire, quantitative sensory tests, and the improvement reported by the patient in terms of arousal and orgasm. The evaluations will be carried out before the treatment, at the end of the treatment and 3, 6 and 12 months after the end of the treatment.


Assuntos
Disfunções Sexuais Fisiológicas , Traumatismos da Medula Espinal , Feminino , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Disfunções Sexuais Fisiológicas/etiologia , Disfunções Sexuais Fisiológicas/terapia , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/terapia , Nervo Tibial , Vibração/uso terapêutico
3.
Artigo em Inglês | MEDLINE | ID: mdl-35162525

RESUMO

The objective of this study was to evaluate the content, quality, and readability of websites containing information on dyspareunia, vaginismus, and vulvodynia in Spanish. Web pages were retrieved entering the terms "dyspareunia", "vaginismus", and "vulvodynia" in Google, Yahoo!, and Bing search engines. Two researchers employed the DISCERN and Bermúdez-Tamayo questionnaires to analyze the content and quality of the websites, and the INFLESZ scale to evaluate their readability. IBM SPSS® version 25 statistical software was employed for data analysis. The internet search yielded 262 websites, 91 of which were included after applying the selection criteria. Websites with information on dyspareunia obtained median scores of 24 (30-21) in the DISCERN, 38 (41.0-35.5) in the Bermúdez-Tamayo, and 55.3 (57.2-50.9) in the INFLESZ tools. The results for websites on vaginismus revealed median scores of 23.5 (30-20) in the DISCERN, 37 (42-35) in the Bermúdez-Tamayo, and 52.9 (55.6-46.4) in the INFLESZ. Finally, the median scores for vulvodynia sites was 25.5 (30-20) in the DISCERN, 38 (43-33.7) in the Bermúdez-Tamayo, and 54.2 (57.3-47.2) in the INFLESZ. These outcomes indicate that the quality of information in these websites is very low, while the overall quality of the web pages is moderate. Sites on vaginismus and vulvodynia were "somewhat difficult" to read, while readability was "normal" for websites on dyspareunia. Healthcare professionals should be aware of the shortcomings of these websites and address them through therapeutic education with resources containing updated, quality information. This raises the need for health professionals to generate these resources themselves or for experts and/or scientific societies in the field to check the quality and timeliness of the contents, regardless of whether or not the websites are endorsed with quality seals.


Assuntos
Informação de Saúde ao Consumidor , Dispareunia , Vaginismo , Vulvodinia , Compreensão , Feminino , Humanos , Internet
4.
J Clin Med ; 11(1)2022 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-35012011

RESUMO

This study aimed to determine the effectiveness of therapeutic exercise plus patient therapeutic education on perceived fatigue, functional capacity and pain in breast cancer survivors with cancer-related fatigue. A randomised, single-blind, clinical trial was conducted with a total of 80 breast cancer survivors who presented cancer-related fatigue. Women were randomised into a supervised therapeutic exercise group (STE-G) (n = 40) or an unsupervised exercise group (UE-G) (n = 40). Both interventions included patient therapeutic education and were delivered in three sessions per week over eight weeks. The main outcome was perceived fatigue as assessed by the Spanish version of the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). Other evaluated outcomes were pain measured on a visual analogue scale, and distance measured using the 6-Minute Walk Test. Data were collected at baseline, immediately post-intervention, and at three and six months after baseline. Significantly greater improvements across all variables were observed in the STE-G throughout the entire follow-up period with the exception of pain. Conclusions: A supervised therapeutic exercise program plus patient therapeutic education significantly reduce perceived fatigue and increase functional capacity in breast cancer survivors suffering from cancer-related fatigue compared to an unsupervised physical exercise program based on individual preferences with patient therapeutic education.

5.
Children (Basel) ; 8(12)2021 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-34943345

RESUMO

The child's interaction with the natural environment allows different learning opportunities and favors their motor development, which may be affected after a period of environmental deprivation, a consequence of home confinement due to the COVID-19 pandemic. The main objective of the study was to analyze the different areas of motor development, as well as the quality of life of children aged 0 to 3 years old after home confinement by COVID-19 and the possible correlation between both variables, and the influence of parental stimulation on motor development during this time of exclusive interaction with the immediate environment (home and family). A descriptive study was performed. A simple and anonymous questionnaire was created for parents of children between 0 and 3 years old who lived in Spain during the period of home confinement due to COVID-19 (March to June 2020). The measurement instrument used was a questionnaire made in "Google Forms", where the variables were collected: Motor development (measured through the Ages & Stages Questionnaire, ASQ3), Quality of life (assessed with the Pediatric Quality of Life Inventory, PedsQL) and other variables, such as stimulation, performed during home confinement. Eighty-eight questionnaires were validated. The highest score in the motor development domains were obtained in children 2-3 years old. The motor domain of children aged 2-3 years old that obtained the highest score was communication (M = 54.69 ± 10.03) and the highest score in the quality of life was obtained in children aged 0-1 years old (M = 85.47 ± 12.39), also acquiring the lowest score in the emotional domain in all age groups (0-1, 1-2 and 2-3 years old). The assessment of motor development and quality of life after home confinement due to the COVID-19 pandemic did not determine low values, so it would not have been affected during this period of lack of interaction with the natural environment. Emphasizing that the emotional aspect within quality of life was the lowest score, this indicates that children from 0 to 3 years old need more emotional support in situations of variability of daily routines and of family stress.

6.
Children (Basel) ; 8(11)2021 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-34828756

RESUMO

Pediatric palliative care (PPC) is a set of actions aimed at children who suffer from a severe or life-threatening disease to alleviate the symptoms of the disease and improve the quality of life of both the child and his/her family. One of the tools used to control symptoms is physiotherapy; however, its application in the child population has not been thoroughly studied. The main objective of this study was to gather, analyze, and critically evaluate the available scientific evidence on physiotherapy in children who require palliative care through a systematic review of the studies published in the last 10 years in the following databases: PubMed, Cochrane Library, PEDro, CINAHL, and Scopus. Of a total of 622 studies, the inclusion criteria were only met by seven articles, which were focused on the relationship between physiotherapy and PPC. This study analyzed: (1) the main pathologies treated, with a predominance of cerebral palsy and cancer; (2) the interventions applied, such as respiratory physiotherapy, neurological physiotherapy, therapeutic massage, and virtual reality; (3) the effects achieved in the child and his/her family, highlighting the control of symptoms and the improvement of the quality of life; and (4) the knowledge of the physiotherapists on PPC, observing that most of the professionals had not received training in this scope. The findings of this review indicate a lack of an adequate evidence foundation for physiotherapy in PPC.

7.
Ther Adv Chronic Dis ; 12: 20406223211034996, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34408823

RESUMO

BACKGROUND: Children with unilateral spastic cerebral palsy (USCP) receive different treatments, including the application of modified constraint induced movement therapy (mCIMT) or bimanual intensive therapy (BIT) to increase affected upper limb functionality. The aim of this study was to compare the effectiveness of two protocols with different proportions and orders of mCIMT/BIT within combined intensive home-therapy in children with USCP (6-8 years old) with high bimanual functional performance, applied by the family. METHODS: The protocols were performed on 20 children with an average age of 7.12 years [standard deviation (SD): 0.70], allocated to two different combined therapies. The protocols were designed by 100 h of dose for 10 weeks: 80 h of mCIMT followed by 20 h of BIT (mCIMT-B group) and 80 h of BIT followed by 20 h of mCIMT (BIT-mCI group). Bimanual functional performance was measured with Assisting Hand Assessment Scale (AHA) and the affected upper limb-use experience with Children's Hand-use Experience Questionnaire (CHEQ). Parent satisfaction and expectations with therapy were measured using a specific questionnaire. There were five assessment timepoints (week 0, week 4, week 8, week 10 and week 34). RESULTS: There were no statistically significant (p > 0.05) inter- and intra-group changes in the bimanual functional performance of both groups. The affected upper limb-use experience obtained significant changes in BIT-mCI group, with statistically significant differences in the pairwise comparisons between week 0-10 and week 4-10 (p = 0.028) for use of the affected hand and the use of the affected hand to grasp between week 4 and week 8 (p = 0.028). Grasp efficacy and discomfort acquired statistically significant differences only in the BIT-mCI group for pairwise comparisons week 0-week 10/week 4-week 10 (p = 0.035). Although task execution time compared with a typically developing child of the same age obtained statistically significant differences only in the group mCIMT-B for pairwise comparisons week 0-week 8 (p = 0.03), week 0-week 10 (p = 0.03), week 4-week 8 (p = 0.04) and week 4-week 10 (p = 0.03). Family satisfaction and expectations acquired an increase between week 0 and week 10 (p ⩽ 0.02). CONCLUSION: Applying 80 h of BIT for 8 weeks in children with high bimanual functional performance USCP (6-8 years old), executed at home with family involvement would be sufficient to obtain improvements in affected upper limb-use experience, without the need to use combined protocols of 100 h. However, no statistically significant increase in bimanual functional performance would be obtained, with the basal situation of the child being a factor to consider for the execution of mCIMT and BIT.Registration number and name of trial registry: [ClinicalTrials.gov identifier: NCT03465046].

8.
Medicina (B Aires) ; 81(3): 367-374, 2021.
Artigo em Espanhol | MEDLINE | ID: mdl-34137695

RESUMO

Cerebral palsy and Down syndrome are two conditions that present with a deficit in motor development. Treadmill interventions were found to improve this delay in development. This work aimed to describe and analyze the methodological quality of studies that applied treadmill interventions alone or combined with other therapies to promote gait and balance in children under 12 years of age with cerebral palsy and Down syndrome. A systematic review was made in different databases: PubMed, PEDro, Cochrane and Science Direct. Only randomized clinical trials published to date were selected. The methodological quality of the identified studies was assessed using the PEDro scale. Of the 324 articles initially found, 10 were selected, which met the established inclusion criteria for qualitative analysis. The variables analyzed were gait and balance in both populations after the treadmill intervention, with and without suspension of body weight. The main conclusion was that the application of a treadmill alone is an effective intervention to promote the development of gait and balance in children under 12 years with cerebral palsy and Down syndrome.


La parálisis cerebral y el síndrome de Down son dos afecciones que cursan con déficit del desarrollo motor. Este retraso mejora con el uso de cinta rodante. Se realizó una revisión sistemática en diferentes bases de datos con el propósito de analizar estudios y s u calidad metodológica en relación a la aplicación del uso exclusivo de cinta rodante y su combinación con otras terapias para fomentar la marcha y equilibrio en niños menores de 12 años con parálisis cerebral y síndrome de Down. Se seleccionaron únicamente ensayos clínicos aleatorizados publicados hasta la fecha en PubMed, PEDro, Cochrane y Science Direct. La calidad metodológica de los estudios identificados se evaluó a través de la escala PEDro. De los 324 artículos inicialmente encontrados, se seleccionaron los 10 que cumplieron con los criterios de inclusión establecidos para su análisis cualitativo. Las variables analizadas fueron la marcha y el equilibrio en ambas poblaciones tras la intervención con cinta rodante, con y sin suspensión del peso corporal. Concluimos que la aplicación de cinta rodante como única herramienta terapéutica resulta una intervención eficaz para favorecer el desarrollo de la marcha y el equilibrio en niños de 0 a12 años con parálisis cerebral y síndrome de Down.


Assuntos
Paralisia Cerebral , Síndrome de Down , Peso Corporal , Criança , Síndrome de Down/terapia , Teste de Esforço , Terapia por Exercício , Marcha , Humanos
9.
Medicina (B.Aires) ; 81(3): 367-374, jun. 2021. graf
Artigo em Espanhol | LILACS | ID: biblio-1346471

RESUMO

Resumen La parálisis cerebral y el síndrome de Down son dos afecciones que cursan con déficit del desarrollo motor. Este retraso mejora con el uso de cinta rodante. Se realizó una revisión sistemática en dife rentes bases de datos con el propósito de analizar estudios y s u calidad metodológica en relación a la aplicación del uso exclusivo de cinta rodante y su combinación con otras terapias para fomentar la marcha y equilibrio en niños menores de 12 años con parálisis cerebral y síndrome de Down. Se seleccionaron únicamente ensayos clínicos aleatorizados publicados hasta la fecha en PubMed, PEDro, Cochrane y Science Direct. La calidad me todológica de los estudios identificados se evaluó a través de la escala PEDro. De los 324 artículos inicialmente encontrados, se seleccionaron los 10 que cumplieron con los criterios de inclusión establecidos para su análisis cualitativo. Las variables analizadas fueron la marcha y el equilibrio en ambas poblaciones tras la intervención con cinta rodante, con y sin suspensión del peso corporal. Concluimos que la aplicación de cinta rodante como única herramienta terapéutica resulta una intervención eficaz para favorecer el desarrollo de la marcha y el equilibrio en niños de 0 a12 años con parálisis cerebral y síndrome de Down.


Abstract Cerebral palsy and Down syndrome are two conditions that present with a deficit in motor development. Treadmill interventions were found to improve this delay in development. This work aimed to describe and analyze the methodological quality of studies that applied treadmill interventions alone or combined with other therapies to promote gait and balance in children under 12 years of age with cerebral palsy and Down syndrome. A systematic review was made in different databases: PubMed, PEDro, Cochrane and Science Direct. Only randomized clinical trials published to date were selected. The methodological quality of the identified studies was assessed using the PEDro scale. Of the 324 articles initially found, 10 were selected, which met the established inclusion criteria for qualitative analysis. The variables analyzed were gait and bal ance in both populations after the treadmill intervention, with and without suspension of body weight. The main conclusion was that the application of a treadmill alone is an effective intervention to promote the development of gait and balance in children under 12 years with cerebral palsy and Down syndrome.


Assuntos
Humanos , Criança , Paralisia Cerebral , Síndrome de Down/terapia , Peso Corporal , Teste de Esforço , Terapia por Exercício , Marcha
10.
Children (Basel) ; 8(5)2021 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-33922203

RESUMO

Infantile hemiparesis may be associated with significant morbidity and may have a profound impact on a child's physical and social development. Infantile hemiparesis is associated with motor dysfunction as well as additional neurologic impairments, including sensory loss, mental retardation, epilepsy, and vision, hearing, or speech impairments. The objective of this study was to analyze the association between the cause of infantile hemiparesis and birth (gestational age), age of diagnosis, and associated disorders present in children with infantile hemiparesis aged 0 to 3 years. An observational and cross-sectional study was performed. A simple and anonymous questionnaire was created ad hoc for parents of children diagnosed with infantile hemiparesis aged between 0 and 3 years about the situation regarding the diagnosis of hemiparesis, birth, cause of hemiparesis, and presence of other associated disorders. Perinatal stroke (60.1%) was the most common cause of hemiparesis, and the most typical associated disorder was epilepsy (34.2%), with the second largest percentage in this dimension corresponding to an absence of associated disorders (20.7%). The most frequent birth was "no premature" (74.1%). The mean age of diagnosis of infantile hemiparesis was registered at 8 months (IQR: 0-36). Knowing the possible association between different conditioning factors and the cause of infantile hemiparesis facilitates the prevention of severe sequelae in children and family, implementing an early comprehensive therapeutic approach in children with infantile hemiparesis.

11.
J Clin Med ; 10(3)2021 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-33540507

RESUMO

Aging processes in the musculoskeletal system lead to functional impairments that restrict participation. Purpose: To assess differences in the force and motor recruitment patterns of shoulder muscles between age groups to understand functional disorders. A cross-sectional study comparing 30 adults (20-64) and 30 older adults (>65). Surface electromyography (sEMG) of the middle deltoid, upper and lower trapezius, infraspinatus, and serratus anterior muscles was recorded. Maximum isometric voluntary contraction (MIVC) was determined at 45° glenohumeral abduction. For the sEMG signal registration, concentric and eccentric contraction with and without 1 kg and isometric contraction were requested. Participants abducted the arm from 0° up to an abduction angle of 135° for concentric and eccentric contraction, and from 0° to 45°, and remained there at 80% of the MIVC level while isometrically pushing against a handheld dynamometer. Differences in sEMG amplitudes (root mean square, RMS) of all contractions, but also onset latencies during concentric contraction of each muscle between age groups, were analyzed. Statistical differences in strength (Adults > Older adults; 0.05) existed between groups. No significant differences in RMS values of dynamic contractions were detected, except for the serratus anterior, but there were for isometric contractions of all muscles analyzed (Adults > Older adults; 0.05). The recruitment order varied between age groups, showing a general tendency towards delayed onset times in older adults, except for the upper trapezius muscle. Age differences in muscle recruitment patterns were found, which underscores the importance of developing musculoskeletal data to prevent and guide geriatric shoulder pathologies.

12.
Physiotherapy ; 110: 54-62, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32718746

RESUMO

OBJECTIVE: To examine the effects of a 6-week surface electromyographic biofeedback intervention on the re-learning of upper extremity motor function in subjects with paretic upper extremity after stroke. DESIGN: A randomized controlled trial. SETTING: State Centre of Attention to Brain Injury, Madrid, Spain. PARTICIPANTS: Thirty-eight participants in the sub-acute post-stroke stage were recruited and randomly allocated into either the surface electromyographic biofeedback (sEMG-BFB) or sham biofeedback (BFB) groups. INTERVENTIONS: The sEMG-BFB group (n=19) received the intervention focused on re-learning scapulothoracic control during arm-reaching tasks involving shoulder abduction. The sham BFB group (n=19) received a sham intervention. OUTCOME MEASURES: Upper extremity motor function assessed using the Fugl-Meyer Assessment-Upper Extremity Scale (66 points), the glenohumeral active range of motion, and the electromyographic amplitude signal of the middle deltoid and upper trapezius muscles were collected at baseline, after the intervention, and at the one-month follow-up. RESULTS: Compared with the sham BFB group, the sEMG-BFB group experienced significant increases in upper extremity motor function after the intervention. The mean differences between groups were as follows: 4.79 points (95% CI 2.92 to 6.66) after the intervention; 6.55 points (95% CI 3.75 to 9.34) at the one-month follow-up; improved active range of motion 15.75 points (95% CI 6 to 30) after the intervention and electromyographic activity in the upper trapezius muscle changed in favour of the sEMG-BFB. CONCLUSIONS: In the short term, a 6-week sEMG-BFB intervention effectively improved paretic upper limb motor function. Future research is needed to determine if the sEMG-BFB intervention has any long-term effects. Clinical trial number registration: NCT02974465 (ClinicalTrials.gov).


Assuntos
Eletromiografia/métodos , Retroalimentação Sensorial/fisiologia , Reabilitação do Acidente Vascular Cerebral/métodos , Extremidade Superior/fisiopatologia , Adulto , Humanos , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Método Simples-Cego
13.
J Women Aging ; 31(6): 492-512, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30252611

RESUMO

We conducted a cross-sectional study to assess differences in neuromotor attributes of shoulder muscles between age groups in both sexes and to better understand functional disorders in older women. Twenty young (20-42 years old), 20 middle-aged (43-67), and 20 older (> 68) adults participated in a comparative surface-electromyography study of five muscles. We identified age-related differences in women, especially in scapula stabilizer muscles. There was a tendency for both sexes of delayed onset times with increasing age, excepting the upper trapezius muscle in females. The results highlight the importance of understanding musculoskeletal aging in women to adequately guide physical therapeutic approaches.


Assuntos
Fatores Etários , Envelhecimento/fisiologia , Eletromiografia/estatística & dados numéricos , Fatores Sexuais , Músculos Superficiais do Dorso/fisiologia , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ombro/fisiologia , Adulto Jovem
14.
J Chiropr Med ; 14(4): 249-58, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26793036

RESUMO

OBJECTIVE: The purpose of this study was to evaluate the feasibility of the methods proposed to conduct a full randomized clinical trial to assess the effectiveness of mobilization with movement on shoulder functionality in older adults with shoulder dysfunction. METHODS: A pilot, randomized, single-blinded clinical trial was carried out with 44 older adults (83.9±8.2 years) with shoulder dysfunction in 3 nursing homes in Toledo, Spain. Participants were recruited through information sessions and were randomly allocated into 2 groups. The control group (n = 22) intervention consisted of a physical therapy standard protocol proposed by the Spanish Rheumatology Society. Techniques based on Mulligan's concepts of mobilization with movement were added to the standard protocol for the experimental group (n = 22) intervention. Interventions took place 3 times a week for 2 consecutive weeks and were performed by 2 experienced therapists. Main outcomes were recruitment rates, participation and adherence to interventions, assessment procedures, and the implementation of mobilization with movement. Clinical outcomes were shoulder functionality, active glenohumeral range of motion, and pain intensity. Data were collected at baseline, after each group intervention, and at 1 and 3 months after finishing interventions. RESULTS: All the participants accepted to be randomized. Participation rates were 97.7% for the experimental group and 95.5% for the control group. The analysis of variance did not show any statistically significant difference between treatment groups for any of the variables (all P values for the group effect were greater than .36) or a change of the difference between groups over time (all P values for the time-treatment interactions were greater than .3). CONCLUSION: The research methods tested in this pilot study offer a suitable foundation to conduct a full clinical trial.

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