Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Azhar University - Gaza
About this trial
This randomized controlled trial will evaluate the effectiveness of dual-task balance training on balance, mobility, and mental health among traumatic lower-limb prosthesis users in the Gaza Strip. Participants will be randomly assigned to either an experimental group receiving dual-task balance training in addition to standard rehabilitation or a control group receiving standard rehabilitation only. The intervention will be delivered over 6 weeks, with three sessions per week. Balance and mobility will be assessed using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis, while mental health will be assessed using the Depression, Anxiety, and Stress Scale-21.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Traumatic unilateral lower-limb amputation.
Transtibial or transfemoral amputation level.
Current lower-limb prosthesis user.
Disqualifiers
Lower-limb amputation due to dysvascular, congenital, or non-traumatic causes.
Bilateral lower-limb amputation.
Severe cognitive impairment that prevents understanding or following study instructions.
Severe visual, vestibular, neurological, or musculoskeletal condition that significantly affects balance or walking independent of the amputation.
Trial design
Design model
Parallel
Treatments tested in this trial
Dual-Task Balance Training
BehavioralA 6-week rehabilitation program consisting of progressive balance training combined with concurrent cognitive or motor tasks. Sessions will be conducted three times per week and will be adapted according to participant ability and safety level.
Standard Rehabilitation
BehavioralUsual rehabilitation care provided for lower-limb prosthesis users, including therapeutic exercises, gait training, balance activities, and functional mobility training according to the participant's clinical needs.
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Dual-Task Balance Training GroupExperimental treatment 2 interventions
Group B: Standard Rehabilitation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Balance as Assessed by the Berg Balance Scale
Balance will be assessed using the Berg Balance Scale (BBS), which consists of 14 functional balance tasks. The total score ranges from 0 to 56, with higher scores indicating better balance performance. Change in balance will be calculated as the Week 6 score minus the baseline score.
Time frame
Baseline (Day 0) and Week 62
Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis
Mobility will be assessed using the Amputee Mobility Predictor with Prosthesis (AMPPro), which evaluates functional mobility in lower-limb prosthesis users through 21 mobility tasks. The total score ranges from 0 to 47, with higher scores indicating better functional mobility. Change in mobility will be calculated as the Week 6 score minus the baseline score.
Time frame
Baseline (Day 0) and Week 6Secondary outcomes
1
Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21
Mental health symptoms will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21), a 21-item self-report instrument comprising three subscales: depression, anxiety, and stress, with 7 items in each subscale. Each item is scored from 0 to 3. The item scores for each subscale are summed and multiplied by 2, resulting in a score range of 0 to 42 for each subscale. Higher scores indicate greater severity of depression, anxiety, or stress symptoms. Change in each subscale score will be calculated as the Week 6 score minus the baseline score.
Time frame
Baseline (Day 0) and Week 6Sponsors and contacts
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Source ClinicalTrials.gov