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

NCT07731698 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-1097
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfemoral Amputation; Balance Impairment; Fall Risk

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 8 weeks of intervention

Secondary Outcomes (1)

• Berg Balance Scale (BBS)

  Baseline and after 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Participants receive dual-task training in addition to conventional physiotherapy for 8 weeks.

Behavioral: Dual-task training

Control

ACTIVE COMPARATOR

Participants receive conventional physiotherapy only for 8 weeks.

Other: Conventional Physiotherapy

Interventions

Dual-task training BEHAVIORAL

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.

Experimental

Conventional Physiotherapy OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Armed forces Center for Health Rehabilitation in Taif

Ta'if, Saudi Arabia

Location

Central Study Contacts

Khalid S Muhanna, PT

CONTACT

+966559993635; Pt.khalid.almuhanna@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Faculty of Physical Therapy, Kafrelsheikh University

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 26, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

SA (1)