Effect on Hand Function After Six-week Use of a Wearable Soft-Robotic Glove Assisting ADL: Interim Results of an Ongoing Clinical Study.

In an ongoing study, an assistive wearable soft-robotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable soft-robotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand).

BACKGROUND: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). METHODS: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. RESULTS: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. CONCLUSIONS: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. TRIAL REGISTRATION: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34200.

Can telerehabilitation services combined with caregiver-mediated exercises improve early supported discharge services poststroke? A study protocol for a multicentre, observer-blinded, randomized controlled trial.

BACKGROUND: Recovery of walking ability is an important goal for patients poststroke, and a basic level of mobility is critical for an early discharge home. Caregiver-mediated exercises could be a resource-efficient strategy to augment exercise therapy and improve mobility in the first months poststroke. A combination of telerehabilitation and face-to-face support, blended care, may empower patient-caregiver dyads and smoothen the transition from professional support to self-management. The Armed4Stroke study aims to investigate the effects of a caregiver-mediated exercise program using a blended care approach in addition to usual care, on recovery of mobility in the first 6 months poststroke. METHODS: A multicentre, observer-blinded randomized clinical trial in which 74 patient-caregiver dyads will be enrolled in the first 3 months poststroke. Dyads are randomly allocated to a caregiver-mediated exercises intervention or to a control group. The primary endpoint is the self-reported mobility domain of the Stroke Impact Scale. Secondary endpoints include care transition preparedness and psychological functioning of dyads, length of inpatient stay, gait-related measures and extended ADL of patients, and caregiver burden. Outcomes are assessed at enrolment, end of treatment and 6 months follow-up. RESULTS: During 8 weeks, caregivers are trained to become an exercise coach using a blended care approach. Dyads will receive a tailor-made, progressive training program containing task-specific exercises focusing on gait, balance, physical activity and outdoor activities. Dyads are asked to perform the training program a minimum of 5 times a week for 30 min per session, supported by a web-based telerehabilitation system with instruction videos and a messaging environment to communicate with their physiotherapist. CONCLUSIONS: We hypothesize that the Armed4Stroke program will increase self-reported mobility and independence in ADL, facilitating an early discharge poststroke. In addition, we hypothesize that active involvement of caregivers and providing support using blended care, will improve the care transition when professional support tapers off. Therefore, the Armed4Stroke program may complement early supported discharge services. TRIAL REGISTRATION: Netherlands Trial Register, NL7422 . Registered 11 December 2018.

The effect of ankle-foot orthoses on fall/near fall incidence in patients with (sub-)acute stroke: A randomized controlled trial.

Falls are commonly reported post-stroke. Ankle-foot orthoses (AFOs) are often provided to improve safety and walking, but the effect of their use in the reduction of falls after stroke is unknown. A randomized controlled trial (RCT) on the effects of AFO-provision after stroke was performed. Effects on clinical scales, 3D-gait kinematics and muscle-activity were previously reported. This paper aims to study the effects of AFO-provision on occurrence and circumstances of falls/near falls. The RCT included unilateral hemiparetic stroke patients. AFOs were provided either early (study week 1) or delayed (study week 9). Both groups were compared in the first eight weeks of the study and diaries were used to register falls/near falls and their circumstances. Follow-up measurements were performed in week 9-52, in which both groups were provided with AFOs. Functional Ambulation Categories and Berg Balance Scale were assessed to determine walking independence and balance, respectively. Last known scores were noted in case of an incident. Thirty-three subjects were included (16 early, 17 delayed). In week 1-8, the early group, who were provided with AFOs, fell significantly more frequently compared with the delayed group, 11 versus 4 times, respectively (Incidence Rate Ratio = 2.9, p = 0.039). Out of the falls recorded in the early group, 63.6% occurred without wearing AFOs. Most of these falls occurred during transfers (36.4%) and standing (27.3%), and notably it were the subjects who did not have independent walking ability. No differences were found for near falls in week 1-8, or for falls/near falls in week 9-52. Six severe consequences (including fractures) were reported from a fall. To conclude, the subjects provided with AFOs early after stroke reported a higher number of falls, compared to the subjects that had not yet been provided with AFOs. However, in the subjects provided with AFOs, 63.6% of the falls occurred whilst without wearing the AFO. Furthermore, the majority of these incidents took place whilst subjects had no independent walking ability. This raises an interesting question of the importance of careful instructions to patients and their relatives, and the influence of potential cognitive impairments on the ability of the subjects to take on these instructions.

Effect of long-term use of ankle-foot orthoses on tibialis anterior muscle electromyography in patients with sub-acute stroke: A randomized controlled trial.

OBJECTIVE: To determine: (i) whether the use of ankle-foot orthoses over a period of 26 weeks affects tibialis anterior muscle activity; (ii) whether the timing of provision of ankle-foot orthoses (early or delayed) affects the results; (iii) whether the provision of ankle-foot orthoses affects tibialis anterior muscle activity within a single measurement. DESIGN: Randomized controlled trial. SUBJECTS: Unilateral hemiparetic subjects, a maximum of 6 weeks post-stroke. METHODS: Subjects were assigned randomly to early (at inclusion; week 1) or delayed provision of ankle-foot orthoses (8 weeks later; week 9). Tibialis anterior electromyography was measured with and without ankle-foot orthoses, in study weeks 1, 9, 17 and 26. RESULTS: A total of 26 subjects were analysed. In a single measurement, use of an ankle-foot orthosis significantly reduced the activity levels of the tibialis anterior muscle during the swing phase (p = 0.041) compared with walking without an ankle-foot or-thosis. During the 26-week follow-up, no changes were found in tibialis anterior muscle activity in the swing phase without an ankle-foot orthosis, both within-groups (p = 0.420 early; p = 0.282 delayed), and between-groups (p = 0.987). After 26 weeks, no differences were found in tibialis anterior muscle activity between both groups in the swing phase, with (p = 0.207) or without ankle-foot orthoses (p = 0.310). CONCLUSION: Use of ankle-foot orthoses post-stroke reduced tibialis anterior muscle activity in the swing phase within 1 measurement; however, long-term use of ankle-foot orthoses for 26 weeks did not affect such activity. Early or delayed provision of ankle-foot orthoses did not affect the findings. The results indicate that there is no need to fear negative consequences on tibialis anterior-activity because of long-term AFO-use (early) after stroke.

The influence of early or delayed provision of ankle-foot orthoses on pelvis, hip and knee kinematics in patients with sub-acute stroke: A randomized controlled trial.

BACKGROUND: Compensatory pelvis, hip- and knee movements are reported after stroke to overcome insufficient foot-clearance. Ankle-foot orthoses (AFOs) are often used to improve foot-clearance, but the optimal timing of AFO-provision post-stroke is unknown. Early AFO-provision to prevent foot-drop might decrease the development of compensatory movements, but it is unknown whether timing of AFO-provision affects post-stroke kinematics. RESEARCH QUESTIONS: 1) To compare the effect of AFO-provision at two different points in time (early versus delayed) on frontal pelvis and hip, and sagittal hip and knee kinematics in patients with sub-acute stroke. Effects were assessed after 26 weeks; 2) To study whether possible changes in kinematics or walking speed during the 26-weeks follow-up period differed between both groups. METHOD: An explorative randomized controlled trial was performed, including unilateral hemiparetic patients maximal six weeks post-stroke with indication for AFO-use. Subjects were randomly assigned to AFO-provision early (at inclusion) or delayed (eight weeks later). 3D gait-analysis with and without AFO was performed in randomized order. Measurements were performed in study-week 1, 9, 17 and 26. RESULTS: Twenty-six subjects (15 early, 11 delayed) were analyzed. After 26 weeks, no differences in kinematics were found between both groups for any of the joint angles, both for the without and with AFO-condition. Changes in kinematics during the 26-weeks follow-up period did not differ between both groups for any of the joint angles during walking without AFO. Significant differences in changes in walking speed during the 26-weeks follow-up were found (p = 0.034), corresponding to the first eight weeks after AFO-provision. SIGNIFICANCE: Results indicate that early or delayed AFO-use post-stroke does not influence pelvis, hip and knee movements after 26 weeks, despite that AFO-use properly corrected drop-foot. AFOs should be provided to improve drop-foot post-stroke, but not with the intention to influence development of compensatory patterns around pelvis and hip.

Six-month effects of early or delayed provision of an ankle-foot orthosis in patients with (sub)acute stroke: a randomized controlled trial.

OBJECTIVE: To study the six-month clinical effects of providing ankle-foot orthoses at different moments (early or delayed) in (sub)acute stroke; this is a follow-up to a published trial. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS: Unilateral hemiparetic stroke subjects maximal six weeks post-stroke with indication for ankle-foot orthosis use. INTERVENTIONS: Subjects were randomly assigned to early (at inclusion; week 1) or delayed provision (eight weeks later; week 9). OUTCOME MEASURES: Functional tests assessing balance and mobility were performed bi-weekly for 17 weeks and at week 26. RESULTS: In all, 33 subjects were randomized. No differences at week 26 were found between both groups for any of the outcome measures. However, results suggest that early provision leads to better outcomes in the first 11-13 weeks. Berg Balance Scale ( P = 0.006), Functional Ambulation Categories ( P = 0.033) and 6-minute walk test ( P < 0.001) showed significantly different patterns over time. Clinically relevant but statistically non-significant differences of 4-10 weeks in reaching independent walking with higher balance levels were found, favouring early provision. CONCLUSION: No six-month differences in functional outcomes of providing ankle-foot orthoses at different moments in the early rehabilitation after stroke were found. Results suggest that there is a period of 11-13 weeks in which early provision may be beneficial, possibly resulting in early independent and safe walking. However, our study was underpowered. Further research including larger numbers of subjects is warranted.

A randomized controlled trial on providing ankle-foot orthoses in patients with (sub-)acute stroke: Short-term kinematic and spatiotemporal effects and effects of timing.

Initial walking function is often limited after stroke, and regaining walking ability is an important goal in rehabilitation. Various compensatory movement strategies to ensure sufficient foot-clearance are reported. Ankle-foot orthoses (AFOs) are often prescribed to improve foot-clearance and may influence these strategies. However, research studying effects of actual AFO-provision early after stroke is limited. We conducted an explorative randomized controlled trial and aimed to study the short-term effects of AFO-provision on kinematic and spatiotemporal parameters in patients early after stroke. In addition, we studied whether timing of AFO-provision influenced these effects. Unilateral hemiparetic patients maximal six weeks post-stroke were randomly assigned to AFO-provision: early (at inclusion) or delayed (eight weeks later). Three-dimensional gait-analysis with and without AFO in randomized order was performed within two weeks after AFO-provision. Twenty subjects (8 early, 12 delayed) were analyzed. We found significant positive effects of AFO-provision for ankle dorsiflexion at initial contact, foot-off and during swing (-3.6° (7.3) vs 3.0° (3.9); 0.0° (7.4) vs 5.2° (3.7); and -6.1° (7.8) vs 2.6° (3.5), respectively), all p<0.001. No changes in knee, hip and pelvis angles were found after AFO-provision, except for knee (+2.3°) and hip flexion (+1.6°) at initial contact, p≤0.001. Significant effects of AFO-provision were found for cadence (+2.1 steps/min, p=0.026), stride duration (-0.08s, p=0.015) and single support duration (+1.0%, p=0.002). Early or delayed AFO-provision after stroke did not affect results. In conclusion, positive short-term effects of AFO-provision were found on ankle kinematics early after stroke. Timing of AFO-provision did not influence the results. TRIAL REGISTRATION NUMBER: NTR1930.

Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.

OBJECTIVE: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS: Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. INTERVENTIONS: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). OUTCOME MEASURES: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. RESULTS: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. CONCLUSIONS: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.