Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users

NCT07706452 | Recruiting

• 1 other identifier: AUG-LLA-DTBT-RCT-2026
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Amputation; Prosthesis Users; Balance Impairment; Mobility Limitations

Keywords

Dual-task training; Balance training; Lower-limb prosthesis; Traumatic amputation; Amputee rehabilitation; Berg Balance Scale; Amputee Mobility Predictor; DASS-21; Gaza Strip; Mental health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21

  Baseline (Day 0) and Week 6

Study Arms (2)

Dual-Task Balance Training Group

EXPERIMENTAL

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; Behavioral: Standard Rehabilitation

Standard Rehabilitation Group

ACTIVE COMPARATOR

Participants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users.

Behavioral: Standard Rehabilitation

Interventions

Dual-Task Balance Training BEHAVIORAL

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.

Dual-Task Balance Training Group

Standard Rehabilitation BEHAVIORAL

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.

Dual-Task Balance Training Group; Standard Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University - Gaza: lead

Study Sites (1)

Artificial Limb and Polio Centre

Gaza, Gaza Strip, Palestinian Territories

RECRUITING

MeSH Terms

Conditions

Mobility Limitation; Amputation, Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Personal Satisfaction; Behavior

Central Study Contacts

Rawan Nabil Alessi, MSc Student / BSc PT

CONTACT

+972597288395; Rawan.n.elessi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the rehabilitation intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Researcher

Model Details: Participants will be randomly assigned into two parallel groups. The experimental group will receive dual-task balance training in addition to standard rehabilitation, while the control group will receive standard rehabilitation only. Outcomes will be measured before and after the 6-week intervention period.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)