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- Essai clinique NCT07578948
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise Among Stroke Patients.
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death. This definition includes stroke both due to infarction and due to hemorrhage. Stroke is the second or third most common cause of death, one of the main causes of adult disability worldwide, and a global health problem. The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease. This study aims to evaluate the effects of Task Related Progressive Resistance Training and Modified Otago Exercises on balance and lower limb motor function in stroke patients.
A randomized controlled trial will be conducted over eleven months. Fifty-two stroke patients aged 45 to 65 years will be selected using non-probability convenient sampling technique. Participants will be randomly allocated into two groups using a lottery method. Group A will receive Task-Oriented Progressive Resistance Training which includes functional strengthening activities targeting lower limb muscles, while Group B will undergo Modified Otago Exercise Program which involves balance and strength exercises used to prevent fall in stroke. Interventions will be carried out over eight weeks, with assessments conducted pre- and post-intervention using the Berg Balance Scale (for balance), Fugl-Meyer Assessment (for lower limb motor function) and Mini Mental State Examination (for cognitive function). Data will be analysed using SPSS version 26, applying parametric or non-parametric tests based on data normality.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 45 to 65 years. (9)
- Both genders male and female.
- Clinically diagnosed with ischemic stroke.
- Chronic stroke patients 6 to 10 months.
- Presence of hemiparesis with mild to moderate motor deficits FMA-LE score 34.
- Cognitive impairment MMSE score more than 26.
- Ability to walk at least 10 meters with or without an assistive device
Exclusion Criteria:
- Dementia or major neurocognitive disorder. (6)
- Complete paralysis or unable to participate in active exercise. (11)
- Patients with severe joint pain or arthritis are excluded due to reduce risk of injury and avoid confounding factors.
- Recent fractures, or other musculoskeletal issues limiting exercise participation.
- Suffering from physical diseases that prevent full participation in training.
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: Modified otago exercises
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Warm up Head, neck, back extension, trunk, and ankle movement
Autres noms:
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Comparateur actif: Task oriented progressive resistance training
Participants receive interventions 3 session per week for 4 weeks
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Standing and reaching in different directions for objects beyond arm's length
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
Délai: baseline to 4rth week
|
Fugl-Meyer Assessment of Lower Extremity (FMA-LE) total score interpretation ranges from 0 to 34, with higher scores indicating better motor function.
Generally, a score of 34 represents normal function, while scores below 29 indicate varying degrees of disability.
(15) All FMA-LE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91).
|
baseline to 4rth week
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Berg Balance Scale (BBS)
Délai: Baseline to 4rth week
|
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool.
Administering the BBS takes approximately 15 min.
Each of the 14 items are scored on a 5-level ordinal scale from 0 (-unable to perform or requiring help‖) to 4 (-normal performance‖), thus providing a potential maximum score of 56 points.
(13) test-retest (ICC = 0.96; 95% CI, 0.93-0.98)
and inter-rater (ICC = 0.93; 95% CI, 0.87-0.97)
reliability was excellent
|
Baseline to 4rth week
|
|
Mini Mentel Scale (MMS)
Délai: baseline to 4rth week
|
The Mini-Mental State Examination (MMSE) is a brief test used to screen for cognitive impairment, particularly in older adults.
It assesses different aspects of cognitive function, including orientation, attention, memory, and language.
The MMSE is scored on a scale of 0-30, with a score of 24 or higher generally considered normal.
(17) The Mini-Mental State Examination (MMSE) generally demonstrates good internal consistency reliability, as indicated by Cronbach's alpha values ranging from 0.78 to 0.81.
|
baseline to 4rth week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sabiha Arshad, MS, Riphah International University
Publications et liens utiles
Publications générales
- Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- Cekmece C, Sade I, Ozcan E, Balci S. Investigation of the effect of task-oriented occupational therapy on daily living activity performance in chronic stroke patients. Pak J Med Sci. 2024 Jul;40(6):1214-1218. doi: 10.12669/pjms.40.6.7954.
- Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/RCR&AHS/25/0214
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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