Transfemoral AmputationDTBALANCENCT07731698
Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis
A study testing Dual-task training and Conventional Physiotherapy in people with Transfemoral Amputation and Balance Impairment, run by Kafrelsheikh University at 1 site in Saudi Arabia.
Trial summary
This prospective randomized controlled trial aims to investigate the effect of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transfemoral Amputation, Balance Impairment, Fall Risk
- What is being tested?
- Dual-task training and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Jul 2026to 1 Feb 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranging from 18 to 60 years.
- Unilateral transfemoral amputation.
- Use of a prosthetic limb for at least 6 months.
- Ability to walk independently with or without assistive devices.
- Medically stable condition.
- Ability to understand and follow study instructions.
Who cannot join
- Bilateral amputation.
- Severe visual or vestibular disorders.
- Neurological conditions (e.g., stroke, Parkinson's disease)
- Cognitive impairment affecting task performance.
- Musculoskeletal conditions affecting the intact limb.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Armed forces Center for Health Rehabilitation in Taif
Ta'if
Abdulgader A Almutairi, Master degree, +966564427912, Abdulgadr1927@hotmail.com
About this study
Official title: Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis: A Randomized Controlled Trial
This prospective randomized controlled trial aims to investigate the effect of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18-60 years will be randomly allocated to either an experimental group receiving dual-task training in addition to conventional therapy or a control group receiving conventional therapy alone. The intervention will be conducted for 8 weeks, 3 sessions per week. Balance and fall risk will be evaluated before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test.
Read the detailed description
Lower limb amputation is associated with impaired balance, gait asymmetry, and an increased risk of falls due to loss of proprioceptive input and biomechanical alterations. Individuals with transfemoral amputation frequently encounter difficulties performing everyday activities that require simultaneous motor and cognitive tasks. Dual-task training has emerged as a rehabilitation strategy designed to improve automaticity of movement, balance control, and functional mobility under real-life conditions.
This study is a prospective randomized controlled trial designed to evaluate the effectiveness of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18 to 60 years who have used a prosthetic limb for at least six months and are able to walk independently will be randomly assigned to either an experimental group or a control group. Randomization will be performed using a computer-generated randomization sequence with allocation concealment by sealed opaque envelopes.
The experimental group will receive conventional physiotherapy combined with dual-task training, including motor-cognitive and motor-motor activities such as walking while counting backward, naming categories, obstacle negotiation with memory tasks, carrying objects during walking, and ball passing. The control group will receive conventional physiotherapy consisting of strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional training. Both groups will participate in supervised treatment sessions three times per week for eight weeks, with each session lasting 45-60 minutes.
Outcome measures will be collected before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test. The study aims to determine whether adding dual-task training to conventional rehabilitation improves balance and reduces fall risk more effectively than conventional therapy alone in individuals with unilateral transfemoral amputation using a prosthesis.
- Conditions
- Transfemoral Amputation, Balance Impairment, Fall Risk
- Being tested
- Dual-task training, Conventional Physiotherapy
- Keywords
- Dual-task training, Transfemoral amputation, Lower limb amputation, Prosthesis, Balance, Fall risk, Gait, Physical therapy, Rehabilitation, Prosthetic training, Randomized controlled trial (RCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingBehavioural
Participants will receive progressive dual-task training combined with conventional physiotherapy. The intervention includes simultaneous motor-cognitive and motor-motor tasks such as walking while counting backward, naming categories, carrying objects during walking, obstacle negotiation, and ball passing. Training will be provided three sessions per week for 8 weeks.
Conventional PhysiotherapyOther
Participants will receive conventional physiotherapy including strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional mobility training for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants receive dual-task training in addition to conventional physiotherapy for 8 weeks. Receives: Behavioral: Dual-task training |
| Control | Active comparator | Participants receive conventional physiotherapy only for 8 weeks. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance assessed using the Biodex Stability System Overall Stability Index (OSI)
Balance will be evaluated using the Biodex Stability System by measuring the Overall Stability Index (OSI). Lower OSI values indicate better postural stability. Assessments will be performed before and after the 8-week intervention.
Measured: Baseline and after 8 weeks of intervention
Secondary outcomes (1)
Berg Balance Scale (BBS)
Balance will be assessed using the Berg Balance Scale (BBS). Higher scores indicate better balance performance.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start26 Jul 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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 to one of two parallel groups. The experimental group will receive dual-task training combined with conventional physiotherapy, while the control group will receive conventional physiotherapy only. Both groups will receive treatment for 8 weeks with pre- and post-intervention assessments.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Saleh Kamal Muhanna, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731698
- Sponsor's protocol ID
- KFSIRB200-1097
- Acronym
- DTBALANCE
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731698
- Acronym / sponsor ID
- DTBALANCE / KFSIRB200-1097
- Conditions
- Transfemoral Amputation, Balance Impairment, Fall Risk
- Keywords
- Dual-task training, Transfemoral amputation, Lower limb amputation, Prosthesis, Balance, Fall risk, Gait, Physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 26 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 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 prospective randomized controlled trial aims to investigate the effect of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18-60 years will be randomly allocated to either an experimental group receiving dual-task training in addition to conventional therapy or a control group receiving conventional therapy alone. The intervention will be conducted for 8 weeks, 3 sessions per week. Balance and fall risk will be evaluated before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test.
Detailed description
Lower limb amputation is associated with impaired balance, gait asymmetry, and an increased risk of falls due to loss of proprioceptive input and biomechanical alterations. Individuals with transfemoral amputation frequently encounter difficulties performing everyday activities that require simultaneous motor and cognitive tasks. Dual-task training has emerged as a rehabilitation strategy designed to improve automaticity of movement, balance control, and functional mobility under real-life conditions.
This study is a prospective randomized controlled trial designed to evaluate the effectiveness of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18 to 60 years who have used a prosthetic limb for at least six months and are able to walk independently will be randomly assigned to either an experimental group or a control group. Randomization will be performed using a computer-generated randomization sequence with allocation concealment by sealed opaque envelopes.
The experimental group will receive conventional physiotherapy combined with dual-task training, including motor-cognitive and motor-motor activities such as walking while counting backward, naming categories, obstacle negotiation with memory tasks, carrying objects during walking, and ball passing. The control group will receive conventional physiotherapy consisting of strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional training. Both groups will participate in supervised treatment sessions three times per week for eight weeks, with each session lasting 45-60 minutes.
Outcome measures will be collected before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test. The study aims to determine whether adding dual-task training to conventional rehabilitation improves balance and reduces fall risk more effectively than conventional therapy alone in individuals with unilateral transfemoral amputation using a prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The experimental group will receive dual-task training combined with conventional physiotherapy, while the control group will receive conventional physiotherapy only. Both groups will receive treatment for 8 weeks with pre- and post-intervention assessments.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Dual-task trainingParticipants receive dual-task training in addition to conventional physiotherapy for 8 weeks. |
| Control | Active comparator | Other: Conventional PhysiotherapyParticipants receive conventional physiotherapy only for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ranging from 18 to 60 years.
- Unilateral transfemoral amputation.
- Use of a prosthetic limb for at least 6 months.
- Ability to walk independently with or without assistive devices.
- Medically stable condition.
Key exclusion criteria (5 listed)
- Bilateral amputation.
- Severe visual or vestibular disorders.
- Neurological conditions (e.g., stroke, Parkinson's disease)
- Cognitive impairment affecting task performance.
- Musculoskeletal conditions affecting the intact limb.
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 trainingParticipants will receive progressive dual-task training combined with conventional physiotherapy. The intervention includes simultaneous motor-cognitive and motor-motor tasks such as walking while counting backward, naming categories, carrying objects during walking, obstacle negotiation, and ball passing. Training will be provided three sessions per week for 8 weeks. | Behavioural | Experimental |
| Conventional PhysiotherapyParticipants will receive conventional physiotherapy including strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional mobility training for 8 weeks. | Other | Control |
Primary outcome
Balance assessed using the Biodex Stability System Overall Stability Index (OSI)
Time frame: Baseline and after 8 weeks of intervention
Balance will be evaluated using the Biodex Stability System by measuring the Overall Stability Index (OSI). Lower OSI values indicate better postural stability. Assessments will be performed before and after the 8-week intervention.
1 secondary outcome
Berg Balance Scale (BBS)
Time frame: Baseline and after 8 weeks
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Transfemoral Amputation
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
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 training and Conventional Physiotherapy in people with Transfemoral Amputation and Balance Impairment, run by Kafrelsheikh University at 1 site in Saudi Arabia.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 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 Saudi Arabia. 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 Khalid S Muhanna, PT (+966559993635, Pt.khalid.almuhanna@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance assessed using the Biodex Stability System Overall Stability Index (OSI) (time frame: Baseline and after 8 weeks of intervention). 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 28 Jul 2026.