Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual-task training, Conventional Physiotherapy.
- Who it may be relevant to
- Registry conditions: Transfemoral Amputation, Balance Impairment, Fall Risk. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis: A Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Balance assessed using the Biodex Stability System Overall Stability Index (OSI) [Time frame: Baseline and after 8 weeks of intervention]
Secondary outcome measures (1)
- Berg Balance Scale (BBS) [Time frame: Baseline and after 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- Armed forces Center for Health Rehabilitation in Taif — Ta'if
Identifiers
NCT: NCT07731698 · KFSIRB200-1097