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Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users (DTBT-LLA)

11. juli 2026 opdateret af: Rawan Nabil Alessi, Al-Azhar University - Gaza

Effectiveness of Dual-Task Balance Training on Balance, Mobility, and Mental Health Among Traumatic Lower-Limb Prosthesis Users in the Gaza Strip: A Randomized Controlled Trial

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lower-limb amputation can lead to significant impairments in balance, mobility, functional independence, and psychological well-being. Prosthesis users often experience challenges during walking and daily activities, particularly when they are required to perform a motor task and a cognitive task at the same time. Dual-task balance training is a rehabilitation approach that combines balance exercises with concurrent cognitive or motor tasks to improve postural control, mobility, attention, and functional performance.

This study is a parallel-group randomized controlled trial designed to investigate the effectiveness of dual-task balance training among traumatic lower-limb prosthesis users in the Gaza Strip. Eligible participants will be traumatic transtibial or transfemoral lower-limb prosthesis users who meet the study inclusion criteria and provide informed consent.

Participants will be randomly allocated into two groups. The experimental group will receive dual-task balance training in addition to standard rehabilitation. The control group will receive standard rehabilitation only. The dual-task balance training program will be conducted for 6 weeks, with three sessions per week. Training will include progressive balance activities combined with cognitive or motor secondary tasks, according to the participant's ability and safety level.

The primary outcomes of the study are balance and mobility, measured using the Berg Balance Scale and the Amputee Mobility Predictor with Prosthesis. The secondary outcome is mental health, measured using the Depression, Anxiety, and Stress Scale-21. Outcome measurements will be collected before and after the intervention period by an assessor who is not involved in delivering the intervention.

The study aims to provide evidence on whether adding dual-task balance training to standard rehabilitation can improve balance, mobility, and mental health outcomes among traumatic lower-limb prosthesis users in a resource-limited rehabilitation setting.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

63

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dual-Task Balance Training Group
Participants in this group will receive dual-task balance training in addition to standard rehabilitation. The program will be delivered for 6 weeks, three sessions per week, and will include progressive balance exercises combined with cognitive or motor secondary tasks.
Adfærdsmæssigt: Dual-Task Balance Training
A 6-week rehabilitation program consisting of progressive balance training combined with concurrent cognitive or motor tasks. Sessions will be conducted three times per week and will be adapted according to participant ability and safety level.
Adfærdsmæssigt: Standard Rehabilitation
Usual rehabilitation care provided for lower-limb prosthesis users, including therapeutic exercises, gait training, balance activities, and functional mobility training according to the participant's clinical needs.
Aktiv komparator: Standard Rehabilitation Group
Participants in this group will receive standard rehabilitation only, according to the usual rehabilitation program provided for lower-limb prosthesis users.
Adfærdsmæssigt: Standard Rehabilitation
Usual rehabilitation care provided for lower-limb prosthesis users, including therapeutic exercises, gait training, balance activities, and functional mobility training according to the participant's clinical needs.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Balance as Assessed by the Berg Balance Scale
Tidsramme: Baseline and after 6 weeks of intervention
Balance will be assessed using the Berg Balance Scale. The scale includes 14 functional balance tasks, with higher scores indicating better balance performance.
Baseline and after 6 weeks of intervention
Change in Mobility as Assessed by the Amputee Mobility Predictor With Prosthesis
Tidsramme: Baseline and after 6 weeks of intervention
Mobility will be assessed using the Amputee Mobility Predictor with Prosthesis. The tool evaluates functional mobility among lower-limb prosthesis users, with higher scores indicating better mobility performance.
Baseline and after 6 weeks of intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mental Health as Assessed by the Depression, Anxiety, and Stress Scale-21
Tidsramme: Baseline and after 6 weeks of intervention
Mental health symptoms will be assessed using the Depression, Anxiety, and Stress Scale-21, which measures depression, anxiety, and stress symptoms. Higher scores indicate greater symptom severity.
Baseline and after 6 weeks of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Al-Azhar University - Gaza

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juli 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. oktober 2026

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AUG-LLA-DTBT-RCT-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared due to privacy and confidentiality considerations, as the study includes sensitive health and mental health information. Only aggregated and anonymized study results will be reported.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Amputation af underekstremiteter

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