- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lieza Iftikhar
- Numéro de téléphone: +923000649149
- E-mail: liezaiftikhar.dpt@tuf.edu.pk
Sauvegarde des contacts de l'étude
- Nom: Zahra Khadim
- Numéro de téléphone: 0330 1980604
- E-mail: drzahrakhadim@gmail.com
Lieux d'étude
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 38000
- Recrutement
- Madinah Teaching Hospital
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Contact:
- Lieza Iftikhar
- Numéro de téléphone: +923000649149
- E-mail: liezaiftikhar.dpt@tuf.edu.pk
-
Contact:
- Zahra Khadim
- Numéro de téléphone: 0330 1980604
- E-mail: drzahrakhadim@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Wolf motor function test
Délai: 8 weeks
|
8 weeks
|
|
Action research arm test
Délai: 8 weeks
|
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TUF/EIRB/173/26
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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