Walking Exercise Sustainability Through Telehealth for Veterans With Lower-Limb Amputation: A Study Protocol.

OBJECTIVE: This randomized controlled superiority trial will determine if an 18-month telehealth walking exercise self-management program produces clinically meaningful changes in walking exercise sustainability compared to attention-control education for veterans living with lower-limb amputation. METHODS: Seventy-eight participants with lower-limb amputation (traumatic or nontraumatic) aged 50 to 89 years will be enrolled. Two groups will complete 6 one-on-one intervention sessions, and 6 group sessions over an 18-month intervention period. The experimental arm will receive a self-management program focusing on increasing walking exercise and the control group will receive attention-control education specific to healthy aging. Daily walking step count (primary outcome) will be continuously monitored using an accelerometer over the 18-month study period. Secondary outcomes are designed to assess potential translation of the walking exercise intervention into conventional amputation care across the Veteran Affairs Amputation System of Care. These secondary outcomes include measures of intervention reach, efficacy, likelihood of clinical adoption, potential for clinical implementation, and ability of participants to maintain long-term exercise behavior. IMPACT: The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation through a telehealth home-based walking exercise self-management model. The approach includes 18 months of exercise support from clinicians and peers. Trial results will provide rehabilitation knowledge necessary for implementing clinical translation of self-management interventions to sustain walking exercise for veterans living with lower-limb amputation, resulting in a healthier lifestyle.

Feasibility of repeated session error-augmentation gait training for people with nontraumatic transtibial amputation.

BACKGROUND: Spatiotemporal gait asymmetries are a persistent problem for people with non-traumatic lower-limb amputation. To date, there is limited knowledge of multi-session gait training interventions targeting step length symmetry after non-traumatic amputation. OBJECTIVE: The objective was to evaluate the feasibility and efficacy of an eight-session, treadmill-based error-augmentation gait training (EAT) protocol to improve spatiotemporal gait asymmetry in people with non-traumatic transtibial amputation (TTA). STUDY DESIGN: Pre-post, single group. Methods: The EAT protocol involved eight training sessions (twice per week, four weeks) of supervised split-belt treadmill walking with asymmetrical belt speeds for five, three-minute sets each session. Step length symmetry during overground walking at a self-selected gait speed was assessed prior to, weekly, and one-week after the EAT protocol. Feasibility outcomes included protocol fidelity, safety, participant acceptability, and efficacy. RESULTS: Seven of the eight participants (87.5%) completed the intervention at the prescribed dose. One participant developed a skin blister on their residual limb, which was possibly related to the intervention. No falls, musculoskeletal injuries, or increases in pain occurred. Participants rated EAT as acceptable based on scores on the Intrinsic Motivation Inventory - Interest/Enjoyment subscale (6.6 ± 0.5; mean ± SD). Average between-limb step length Normalized Symmetry Index improved (was reduced) one-week following EAT (2.41 ± 6.6) compared to baseline (5.47 ± 4.91) indicating a moderate effect size (d=0.53). CONCLUSIONS: An eight session EAT program delivered over four weeks using a split-belt treadmill is feasible for people with unilateral non-traumatic TTA and may reduce step length asymmetry up to a week after intervention.

Falls After Dysvascular Transtibial Amputation: A Secondary Analysis of Falling Characteristics and Reduced Physical Performance.

INTRODUCTION: Over half of all people with lower limb amputation (LLA) experience at least one fall annually. Furthermore, the majority of LLAs result from dysvascular health complications, contributing to balance deficits. However, fall-related research specific to dysvascular LLA remains limited. OBJECTIVE: To characterize falls among adults with dysvascular LLA, using an existing Fall-Type Classification Framework and to describe the functional characteristics of participants across the framework categories. DESIGN: Secondary data analysis from two randomized controlled trials. SETTING: Outpatient setting. PARTICIPANTS: People (n = 69) 6 months to 5 years from dysvascular lower extremity amputation, who were ≥50 years of age and independently ambulatory using a prosthesis. INTERVENTION: None. OUTCOME: Descriptions of self-reported falls were collected on a weekly basis for 12 weeks, and analyzed using an existing Fall-Type Classification Framework. Fall frequencies, estimated count, and estimated proportions were compared across all framework categories, with 95% confidence intervals. Functional measures (Timed Up and Go, Two Minute Walk, Five Meter Walk, and average step count) were collected, and averages for each participant who experienced a fall were calculated. RESULTS: Thirty participants (43.5%) reported 42 falls within 12 weeks. A variety of fall types were described. Incidence of falls was highest for intrinsic destabilization sources, from incorrect weight shift patterns during transfer activities. CONCLUSION: Patients with dysvascular LLAs experience a variety of fall types. The high frequency of intrinsically sourced, incorrect weight-shift falls during transfer activities emphasizes the need to focus rehabilitation efforts on improving postural control in patients with dysvascular LLAs during activities such as reaching, turning, and transferring.

Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial.

BACKGROUND: Lower-limb amputation (LLA) due to non-traumatic vascular etiology is linked to extremely low physical activity and high disability. OBJECTIVE: To test the feasibility of a biobehavioral intervention designed to promote physical activity. DESIGN: A randomized, single-blind feasibility trial with a crossover design. SETTING: Veterans Administration Medical Center. PARTICIPANTS: Military veterans (age: 65.7 [7.8] years; mean [standard deviation]) with nontraumatic lower-limb amputation (LLA), randomized to two groups: GROUP1 (n = 16) and GROUP2 (n = 15). Both groups had similar baseline amputation characteristics (level of amputation and time since amputation). INTERVENTIONS: Twelve weekly, 30-minute telehealth sessions of physical activity behavior-change intervention, with GROUP1 participating in weeks 1-12 and GROUP2 in weeks 13-24. GROUP1 noncontact phase in weeks 13-24 and GROUP2 attention control telehealth phase in weeks 1-12. MAIN OUTCOME MEASURES: Feasibility (participant retention, dose goal attainment, intervention acceptability [Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale], safety) and signal of efficacy (free-living physical activity [accelerometer-based average daily step count], Late Life Function and Disability Index - Disability Scale [LLFDI-DS]). RESULTS: Participant retention rate was high (90%), with three participants lost to follow-up during the intervention period. Dose goal attainment was low, with only 10% of participants achieving an a priori walking dose goal. Intervention was rated as acceptable, with mean IMI Interest and Enjoyment score (5.8) statistically higher than the null value of 5.0 (P = .002). There were no between-group differences in adverse event rates (falls: P = .19, lower extremity wounds: P = .60). There was no signal of efficacy for change in average daily step count (d = -0.15) or LLFDI-DS (d = -0.22 and 0.17 for frequency and limitations scales, respectively). CONCLUSIONS: Telehealth delivered biobehavioral intervention resulted in acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability) for people with nontraumatic LLA.

Relationships Among Perceived Functional Capacity, Self-Efficacy, and Disability After Dysvascular Amputation.

BACKGROUND: Prosthesis rehabilitation after dysvascular transtibial amputation (TTA) is focused on optimizing functional capacity with limited emphasis on promoting health self-efficacy. Self-efficacy interventions decrease disability for people living with chronic disease, but the influence of self-efficacy on disability is unknown for people with dysvascular TTA. OBJECTIVES: To identify if self-efficacy mediates the relationship between self-reported functional capacity and disability after dysvascular TTA. DESIGN: Cross-sectional, secondary data analysis. SETTING: Outpatient rehabilitation facilities. PARTICIPANTS: Thirty-eight men (63.6 ± 9.1 years old) with dysvascular TTA. METHODS: Participants had been living with an amputation for less than 6 months and using walking as their primary form of locomotion using a prosthesis. The independent variable, functional capacity, was measured using the Prosthesis Evaluation Questionnaire-Mobility Scale (PEQ-MS). The proposed mediator, self-efficacy, was measured with the Self-Efficacy of Managing Chronic Disease questionnaire (SEMCD). MAIN OUTCOME MEASURE: Disability was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire. RESULTS: The relationship between self-reported functional capacity and disability is partially mediated by self-efficacy. Relationships between WHODAS 2.0 and PEQ-MS (r = -0.61), WHODAS 2.0 and SEMCD (r = -0.51), and PEQ-MS and SEMCD (r = 0.44) were significant (P < .01). Controlling for SEMCD (P = .04), the relationship between PEQ-MS and WHODAS 2.0 remained significant (P < .01). Statistically significant mediation was determined by a bootstrap method for the product of coefficients (95% confidence interval: -2.23, -7.39). CONCLUSIONS: This study provides initial evidence that the relationship between self-reported functional capacity and disability is partially mediated by self-efficacy after dysvascular TTA. The longitudinal effect of self-efficacy should be further examined to identify causal pathways of disability after dysvascular amputation. Furthermore, additional factors contributing to the relationship between self-reported functional capacity and disability need to be identified. LEVEL OF EVIDENCE: III.

Physical activity behavior change for older veterans after dysvascular amputation.

OBJECTIVE: Determine the feasibility of using a physical-activity behavior-change (PABC) intervention for increasing physical activity and reducing disability in Veterans 1-5years following dysvascular lower-limb amputation (LLA). DESIGN: Cross-over, feasibility trial SETTING: VA Geriatric Research Education and Clinical Center and Veterans Homes PARTICIPANTS: 32 Veterans with dysvascular LLA (1-5years after major LLA) INTERVENTION: The home-based study, using telerehabilitation technology, is intended to reduce participant burden by removing transportation and time barriers. Participants will be randomized into two participation periods of three months (Months 1-3 and 4-6). PABC intervention will occur Months 1-3 for GROUP1 and Months 4-6 for GROUP2. During PABC Intervention, participants engage in weekly video interaction with a physical therapist, who uses a collaborative approach to develop self-monitoring, barrier identification, problem solving and action planning skills to improve physical activity. GROUP2 will participate in a no physical activity intervention, attention control in Months 1-3. GROUP1 will have a no contact, intervention "wash-out" period in Months 4-6. MAIN OUTCOME MEASURES: Feasibility will be determined using measures of 1) participant retention, 2) dose goal attainment, 3) participant acceptability, 4) safety, and 5) initial effect size. Effect size will be based on accelerometer-based physical activity and self-report disability using the Late-Life Function and Disability Index. CONCLUSIONS: This study focuses on a prevalent and understudied population with low physical activity and high levels of disability due to dysvascular LLA. The results of this study will guide future development of targeted rehabilitation research to improve long term physical activity and disability outcomes.

Explaining modified 2-min walk test outcomes in male Veterans with traumatic or nontraumatic lower-limb amputation.

Little evidence exists to support the presence of differences in spatiotemporal gait parameters and ambulation ability between those individuals with traumatic and nontraumatic lower-limb amputation (LLA). We conducted an exploratory study of 81 male Veterans with unilateral amputation to quantify differences in spatiotemporal gait parameters and ambulatory mobility between Veterans with traumatic and nontraumatic LLA. Furthermore, we identified variables that significantly contributed to the explanation of variability in modified 2-min walk test distance. All participants completed the modified 2-min walk test and a spatiotemporal gait analysis using an instrumented walkway during a routine physical therapy visit. Veterans with nontraumatic LLA walked significantly shorter mean distances during a modified 2-min walk test than Veterans with traumatic LLA. Variables identified as significant contributors to modified 2-min walk test variability were amputated limb stance time, amputated limb step length, and percentage of the gait cycle spent in double support. These findings demonstrate that differences in spatiotemporal gait parameters and ambulatory mobility exist between Veterans with traumatic and nontraumatic LLA and identify important spatiotemporal parameters of gait contributing to this decline. These parameters should be considered as targets for intervention and future investigation.