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

Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07731698
Acronym
DTBALANCE
Enrollment
40
Registered
2026-07-28
Start date
2026-07-26
Completion date
2027-02-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Impairment, Fall Risk, Transfemoral Amputation

Keywords

Dual-task training, Transfemoral amputation, Lower limb amputation, Prosthesis, Balance, Fall risk, Gait, Physical therapy, Rehabilitation, Prosthetic training, Randomized controlled trial (RCT)

Brief 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. 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

BEHAVIORALDual-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.

OTHERConventional 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.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Balance assessed using the Biodex Stability System Overall Stability Index (OSI)Baseline and after 8 weeks of interventionBalance 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.

Secondary

MeasureTime frameDescription
Berg Balance Scale (BBS)Baseline and after 8 weeksBalance will be assessed using the Berg Balance Scale (BBS). Higher scores indicate better balance performance.

Countries

Saudi Arabia

Contacts

CONTACTKhalid S Muhanna, PT
Pt.khalid.almuhanna@hotmail.com+966559993635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026