- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07604181
Comparative Effects of Telerehabilitation and Clinic Based Constraint Induced Movement Therapy on Upper Limb Function in Sub-Acute Stroke Patients
Stroke constitutes a principal cause of chronic neurological disability globally, frequently precipitating profound upper limb motor impairment that compromises functional autonomy and overall quality of life. Constraint-Induced Movement Therapy (CIMT) represents a rigorously validated neurorehabilitation paradigm grounded in the doctrine of experience-dependent neuroplasticity, promoting cortical reorganization through enforced utilization of the paretic limb while restraining the unaffected extremity. By counteracting learned non-use and emphasizing high- intensity, task-specific training, CIMT substantially augments motor recovery and functional performance. The primary objective of the present study is to comparatively evaluate the efficacy of CIMT delivery-clinic-based rehabilitation and telerehabilitation-in individuals with stroke. A total of 28 participants will be recruited through a non-probability consecutive sampling technique in accordance with explicitly defined inclusion and exclusion criteria, and will subsequently be randomized into two equal groups (n = 14 per group) using the chit-and-draw method to ensure unbiased allocation. Group A will receive CIMT within a clinical setting under direct supervision, whereas Group B will undergo an equivalent intervention via a structured online telerehabilitation platform under complete supervision. The intervention will be administered to both groups for duration of eight weeks. Outcome measures will include the Action Research Arm Test (ARAT), the Wolf Motor Function Test (WMFT), and the Modified Ashworth Scale (MAS) to comprehensively evaluate upper limb motor function and spasticity. Assessments will be conducted at baseline and at the completion of the eight-week intervention period.
Statistical analysis will be performed using SPSS version 23.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Lieza Iftikhar
- Telefonnummer: +923000649149
- E-mail: liezaiftikhar.dpt@tuf.edu.pk
Undersøgelse Kontakt Backup
- Navn: Zahra Khadim
- Telefonnummer: 0330 1980604
- E-mail: drzahrakhadim@gmail.com
Studiesteder
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 38000
- Rekruttering
- Madinah Teaching Hospital
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Kontakt:
- Lieza Iftikhar
- Telefonnummer: +923000649149
- E-mail: liezaiftikhar.dpt@tuf.edu.pk
-
Kontakt:
- Zahra Khadim
- Telefonnummer: 0330 1980604
- E-mail: drzahrakhadim@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Diagnosed cases of ischemic or hemorrhagic stroke. 2. Age between 40-70 years. 3. Both male and female. 4. Presented with stroke for once in a life and in a period of 6 months post stroke.
5. Patient should not have any history of rehabilitation in his/her 6 months post stroke period. 6. Medically stable condition. 7. Ability to understand and follow simple verbal instructions. 8. Minimum active wrist and finger extension required to participate in CIMT.
Exclusion Criteria:
Severe cognitive impairment. 2. Severe spasticity (Modified Ashworth Scale score >3). 3. Other neurological or musculoskeletal disorders affecting upper limb function.
4. Severe aphasia limiting effective communication. 5. Any other musculoskeletal deficits interfering with task performance. 6. Uncontrolled systemic medical conditions. 7. No attendant's support the session. 8. Depression that restrains participant to cooperate during the session.
Studieplan
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: Constraint-Induced Movement Therapy within a clinical setting
|
it is clinic based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use.
Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.
|
|
Eksperimentel: Constraint-Induced Movement Therapy Via Telerehabilitation
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Online Structured Tele Rehabilitation based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use.
Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Wolf motor function test
Tidsramme: 8 weeks
|
8 weeks
|
|
Action research arm test
Tidsramme: 8 weeks
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TUF/EIRB/173/26
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Constraint-Induced Movement Therapy within a clinical setting
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University of BirminghamAfsluttet
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Region Jönköping CountyFuturum - Academy for health and careAfsluttetSlag | Neurologiske sygdomme eller tilstandeSverige
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Riphah International UniversityAfsluttetHemiplegisk cerebral paresePakistan
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Samsung Medical CenterUkendtHemiplegisk cerebral parese med spasticitet (diagnose)Korea, Republikken
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University of Alabama at BirminghamAfsluttetSlag | Parese i øvre ekstremitet | CVA (Cerebrovaskulær Accident)Forenede Stater
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Batterjee Medical CollegeAfsluttetHemiplegisk cerebral parese | SpejlhænderSaudi Arabien
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Texas Scottish Rite Hospital for ChildrenTexas Woman's UniversityAfsluttet
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Montiha AzeemRekruttering
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Riphah International UniversityAfsluttetCerebral Parese | Hemiplegisk cerebral paresePakistan