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Recruiting NCT07706452

NCT07706452 Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users

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Clinical Trial Summary
NCT ID NCT07706452
Status Recruiting
Phase
Sponsor Al-Azhar University - Gaza
Condition Lower Limb Amputation
Study Type INTERVENTIONAL
Enrollment 63 participants
Start Date 2026-07-08
Primary Completion 2026-09-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Dual-Task Balance TrainingStandard Rehabilitation

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 63 participants in total. It began in 2026-07-08 with a primary completion date of 2026-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Contact & Investigator

Central Contact

Rawan Nabil Alessi, MSc Student / BSc PT

✉ Rawan.n.elessi@hotmail.com

📞 +972597288395

Frequently Asked Questions

Who can join the NCT07706452 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07706452 currently recruiting?

Yes, NCT07706452 is actively recruiting participants. Contact the research team at Rawan.n.elessi@hotmail.com for enrollment information.

Where is the NCT07706452 trial being conducted?

This trial is being conducted at Gaza, Palestinian Territories.

Who is sponsoring the NCT07706452 clinical trial?

NCT07706452 is sponsored by Al-Azhar University - Gaza. The trial plans to enroll 63 participants.

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