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Recruiting NCT07706452

Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users

Conditions: Lower Limb Amputation, Prosthesis Users, Balance Impairment, Mobility Limitations

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 63
Sponsor: Al-Azhar University - Gaza

Location: Artificial Limb and Polio Centre Gaza Gaza Strip

Summary

This randomized controlled trial will evaluate the effectiveness of dual-task balance training on balance, mobility, and mental health among traumatic lower-limb prosthesis users in the Gaza Strip. Participants will be randomly assigned to either an experimental group receiving dual-task balance training in addition to standard rehabilitation or a control group receiving standard rehabilitation only. The intervention will be delivered over 6 weeks, with three sessions per week. Balance and mobility will be assessed using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis, while mental health will be assessed using the Depression, Anxiety, and Stress Scale-21.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older. * Traumatic unilateral lower-limb amputation. * Transtibial or transfemoral amputation level. * Current lower-limb prosthesis user. * Able to stand and walk with the prosthesis, with or without an assistive device. * Medically stable and able to participate in a rehabilitation training program. * Able to understand and follow study instructions. * Provides written informed consent. Exclusion Criteria: * Lower-limb amputation due to dysvascular, congenital, or non-traumatic causes. * Bilateral lower-limb amputation. * Severe cognitive impairment that prevents understanding or following study instructions. * Severe visual, vestibular, neurological, or musculoskeletal condition that significantly affects balance or walking independent of the amputation. * Unhealed residual limb wounds, severe pain, or skin problems that prevent safe prosthesis use. * Uncontrolled medical condition that makes participation unsafe. * Participation in another structured balance training program during the study period.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07706452). StuddyBuddy aggregates publicly available trial information.