Lower Limb AmputationDTBT-LLANCT07706452
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
A study testing Dual-Task Balance Training and Standard Rehabilitation in people with Lower Limb Amputation and Prosthesis Users, run by Al-Azhar University - Gaza at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation, Prosthesis Users, Balance Impairment
- What is being tested?
- Dual-Task Balance Training and Standard Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 8 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories1 site, 1 recruiting
- Recruiting
Artificial Limb and Polio Centre
Gaza, Gaza Strip
About this study
Official title: 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.
Read the 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.
- Being tested
- Dual-Task Balance Training, Standard Rehabilitation
- 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
- Medical subject headings
- Mobility Limitation, Amputation, Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task Balance TrainingBehavioural
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.
Standard RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline (Day 0) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start8 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University - Gaza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawan Nabil Alessi, Al-Azhar University - Gaza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706452
- Sponsor's protocol ID
- AUG-LLA-DTBT-RCT-2026
- Acronym
- DTBT-LLA
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07706452
- Acronym / sponsor ID
- DTBT-LLA / AUG-LLA-DTBT-RCT-2026
- Keywords
- Dual-task training, Balance training, Lower-limb prosthesis, Traumatic amputation, Amputee rehabilitation, Berg Balance Scale, Amputee Mobility Predictor, DASS-21
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Al-Azhar University - GazaUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Balance Training Group | Experimental | Behavioral: Dual-Task Balance Training, Behavioral: Standard RehabilitationParticipants 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. |
| Standard Rehabilitation Group | Active comparator | Behavioral: Standard RehabilitationParticipants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task Balance TrainingA 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. | Behavioural | Dual-Task Balance Training Group |
| Standard RehabilitationUsual 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. | Behavioural | Dual-Task Balance Training Group, Standard Rehabilitation Group |
Primary outcome
Change in Balance as Assessed by the Berg Balance Scale
Time frame: Baseline (Day 0) and Week 6
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.
Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis
Time frame: Baseline (Day 0) and Week 6
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.
1 secondary outcome
Change in Depression, Anxiety, and Stress Symptoms as Assessed by the Depression Anxiety Stress Scales-21
Time frame: Baseline (Day 0) and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Balance Training and Standard Rehabilitation in people with Lower Limb Amputation and Prosthesis Users, run by Al-Azhar University - Gaza at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawan Nabil Alessi, MSc Student / BSc PT (+972597288395, Rawan.n.elessi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Balance as Assessed by the Berg Balance Scale (time frame: Baseline (Day 0) and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.