Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users (DTBT-LLA)

Effectiveness of Dual-Task Balance Training on Balance, Mobility, and Mental Health Among Traumatic Lower-Limb Prosthesis Users in the Gaza Strip: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Amputation; Balance Impairment; Mobility Limitations; Prosthesis Users
• Intervention / Treatment: Behavioral: Dual-Task Balance Training; Behavioral: Standard Rehabilitation

Detailed Description

Lower-limb amputation can lead to significant impairments in balance, mobility, functional independence, and psychological well-being. Prosthesis users often experience challenges during walking and daily activities, particularly when they are required to perform a motor task and a cognitive task at the same time. Dual-task balance training is a rehabilitation approach that combines balance exercises with concurrent cognitive or motor tasks to improve postural control, mobility, attention, and functional performance.

This study is a parallel-group randomized controlled trial designed to investigate the effectiveness of dual-task balance training among traumatic lower-limb prosthesis users in the Gaza Strip. Eligible participants will be traumatic transtibial or transfemoral lower-limb prosthesis users who meet the study inclusion criteria and provide informed consent.

Participants will be randomly allocated into two groups. The experimental group will receive dual-task balance training in addition to standard rehabilitation. The control group will receive standard rehabilitation only. The dual-task balance training program will be conducted for 6 weeks, with three sessions per week. Training will include progressive balance activities combined with cognitive or motor secondary tasks, according to the participant's ability and safety level.

The primary outcomes of the study are balance and mobility, measured using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis. The secondary outcome is mental health, measured using the Depression, Anxiety, and Stress Scale-21. Outcome measurements will be collected before and after the intervention period by an assessor who is not involved in delivering the intervention.

The study aims to provide evidence on whether adding dual-task balance training to standard rehabilitation can improve balance, mobility, and mental health outcomes among traumatic lower-limb prosthesis users in a resource-limited rehabilitation setting.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rawan Nabil Alessi, MSc Student / BSc PT; Phone Number: +972597288395; Email: Rawan.n.elessi@hotmail.com

Study Locations

• Palestinian Territories
  • Gaza Strip
    • Gaza, Gaza Strip, Palestinian Territories
      • Recruiting
      • Artificial Limb and Polio Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older.
• Traumatic unilateral lower-limb amputation.
• Transtibial or transfemoral amputation level.
• Current lower-limb prosthesis user.
• Able to stand and walk with the prosthesis, with or without an assistive device.
• Medically stable and able to participate in a rehabilitation training program.
• Able to understand and follow study instructions.
• Provides written informed consent.

Exclusion Criteria:

• 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.
• Unhealed residual limb wounds, severe pain, or skin problems that prevent safe prosthesis use.
• Uncontrolled medical condition that makes participation unsafe.
• Participation in another structured balance training program during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual-Task Balance Training Group; Participants in this group will receive dual-task balance training in addition to standard rehabilitation. The program will be delivered for 6 weeks, three sessions per week, and will include progressive balance exercises combined with cognitive or motor secondary tasks.	Behavioral: Dual-Task Balance Training; A 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.; Behavioral: Standard Rehabilitation; Usual 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.
Active Comparator: Standard Rehabilitation Group; Participants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users.	Behavioral: Standard Rehabilitation; Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) and Week 6
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.	Baseline (Day 0) and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) and Week 6

Collaborators and Investigators

• Sponsor: Al-Azhar University - Gaza

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mental health; Balance training; Dual-task training; Berg Balance Scale; DASS-21; Traumatic amputation; Gaza Strip; Lower-limb prosthesis; Amputee rehabilitation; Amputee Mobility Predictor
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Mobility Limitation; Amputation, Traumatic; Psychological Well-Being
• Other Study ID Numbers: AUG-LLA-DTBT-RCT-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and confidentiality considerations, as the study includes sensitive health and mental health information. Only aggregated and anonymized study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No