- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07578792
Standard vs Dual-Task Hand-Arm Bimanual Training in Post-Stroke Patients
Comparative Effects of Standard and Dual Task Oriented Hand Arm Bimanual Intensive Training on Cognitive Performance, Upper Limb Functions and Coordination Among Post-Stroke Patients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Stroke is a leading cause of long-term disability, commonly resulting in deficits in upper limb function, coordination, and cognitive performance. These impairments significantly affect the ability to perform daily activities and reduce overall quality of life. Rehabilitation strategies that integrate both motor and cognitive components may enhance functional recovery and promote neuroplasticity.
Hand-Arm Bimanual Intensive Training (HABIT) is a task-specific, repetitive, and goal-oriented intervention designed to improve bilateral upper limb function through coordinated use of both hands. While standard HABIT has demonstrated effectiveness in improving motor outcomes, dual-task-oriented HABIT incorporates simultaneous cognitive demands, such as attention and problem-solving, to better simulate real-life functional activities.
This study is a randomized controlled trial designed to compare the effects of standard HABIT and dual-task-oriented HABIT on cognitive performance, upper limb motor function, and coordination among post-stroke patients. A total of 20 participants aged 40-70 years with mild to moderate upper limb impairment will be recruited. Participants will be randomly assigned to either the intervention group receiving a combination of standard and dual-task-oriented HABIT or the control group receiving standard HABIT only. The intervention will be delivered over eight weeks, with three sessions per week.
Outcome measures will include the Fugl-Meyer Assessment for upper limb function, Action Research Arm Test for functional performance, Finger-to-Nose test for coordination, and Montreal Cognitive Assessment for cognitive evaluation. Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
The findings of this study will provide evidence on whether integrating cognitive challenges into bimanual training leads to superior rehabilitation outcomes, supporting more comprehensive and functionally relevant stroke rehabilitation strategies.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: ambreen iqbal, phD
- Telefoonnummer: +923227616154
- E-mail: iqbalambreen8@gmail.com
Studie Contact Back-up
- Naam: Wajeeha zia, phD
- Telefoonnummer: +92323450078
- E-mail: wajeeha.zia@riphah.edu.pk
Studie Locaties
-
-
Punjab Province
-
Narowal, Punjab Province, Pakistan
- Sahara Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Both male and female' genders.
- Adults aged between 40 and 70 years.
- Clinically diagnosed ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI).
- Modified Ashworth Scale 1, 1+ and 2 will be included.
- Presence of mild to moderate upper limb motor impairment (as defined by Fugl Meyer Assessment score range 23-55 or clinical evaluation).
- Ability to comprehend and follow simple verbal instructions.
Exclusion Criteria:
Severe cognitive impairment or expressive/receptive aphasia limiting effective communication. (10)
- Other neurological disorders (e.g., Parkinson's disease) or psychiatric illnesses that could confound results.(11)
- Exclusion of patients with prior upper limb impairments (e.g., arthritis) unrelated to the recent stroke event.(10)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Standard HABIT
Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week.
|
Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week.
|
|
Experimenteel: Dual-Task-Oriented HABIT
Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week.
|
Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Upper Limb Motor Function
Tijdsspanne: Baseline, Week 4, and Week 8
|
Upper limb motor function will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UL), a validated scale evaluating motor recovery, movement control, and coordination in post-stroke patients.
|
Baseline, Week 4, and Week 8
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Ambreen iqbal, phD, Riphah International University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Muhammad Umar Butt
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .