Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis (DTBALANCE)

July 23, 2026 updated by: Khalid Saleh Kamal Muhanna, Kafrelsheikh University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Ta'if, Saudi Arabia
        • Armed forces Center for Health Rehabilitation in Taif
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Participants receive dual-task training in addition to conventional physiotherapy for 8 weeks.
Behavioral: Dual-task training
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.
Active Comparator: Control
Participants receive conventional physiotherapy only for 8 weeks.
Other: Conventional Physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Baseline and after 8 weeks
Balance will be assessed using the Berg Balance Scale (BBS). Higher scores indicate better balance performance.
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 26, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KFSIRB200-1097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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