- ICH GCP
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- Essai clinique NCT07937098
Effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) Along With Conventional Physical Therapy on Upper Limb Function, Strength, Range of Motion, and Spasticity in Patients With Subacute Stroke.
This randomized controlled trial aims to compare the effects of IASTM (Instrument-Assisted Soft Tissue Mobilization) along with conventional physical therapy on function, strength, range of motion, and spasticity of the upper limb in patients with subacute stroke.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ghulam Mohiuddin Ghulam Mohiuddin, DPT, MS-PT NPT
- Numéro de téléphone: +923323817426
- E-mail: ghulammohiuddinrind@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Nazish Rafique Dr Nazish Rafique, DPT, MS-PT NMPT
- Numéro de téléphone: 03002132436
- E-mail: nazish2312@gmail.com
Lieux d'étude
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Balochistan
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Quetta, Balochistan, Pakistan
- Recrutement
- Barkat Medical and Physical-Therapy Center Hazaratown Quetta
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Contact:
- Nazish Rafique, MSPT
- Numéro de téléphone: 03002132436
- E-mail: nazish.rafique@uipt.iiui.edu.pk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- First-ever stroke (ischemic or hemorrhagic) diagnosed via CT/MRI
- Subacute stage (2 weeks to 6 months post-stroke)
- Age 40-60 years
- Upper limb hemiparesis with Modified Ashworth Scale score 2 and 3
- MMSE (Mini-Mental State Examination) score ≥ 24
- Capable of follow simple verbal commands
Exclusion Criteria:
- Severe cognitive impairment affecting the ability to follow instructions.
- Recurrent stroke
- Presence of other neurological disorders such as Parkinson's disease or multiple sclerosis etc.
- Recent upper limb surgery, fractures or musculoskeletal injury affecting the arm or hand.
- Fixed contracture of upper limb joints
- Severe aphasia or inability to follow commands
- Uncontrolled diabetes mellitus, hypertension
- Serious cardiac problems or unstable cardiovascular disease
- Skin conditions, open wounds, or infections affecting upper limb
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: Group A: IASTM + Conventional Physical Therapy
IASTM + Conventional Physical Therapy |
5-10 minutes per session applied to affected upper limb muscles (biceps brachii, brachialis, flexor carpi radialis, flexor carpi ulnaris, thenar and hypothenar muscles) using stainless steel instruments
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Comparateur actif: Group B: Conventional Physical Therapy
Conventional Physical Therapy |
45-minute session.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Modified Ashworth Scale (MAS)
Délai: Baseline, 3rd week, 6th week
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Moderate-good reliability (κ = 0.65-0.78). The modified Ashworth scale will be used to determine the level of spasticity in the participants. The assessment is done by bringing the patient's limb to the possible maximal extension from flexion and then flexion to extension until the point of resistance is met. Scoring is done from 0-4 (0 being normal while 4 being rigid). |
Baseline, 3rd week, 6th week
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Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Délai: Baseline, 3rd week, 6th week
|
It is a stroke-specific, performance-based outcome measure used to assess upper limb motor recovery following a stroke. The FMA-UE consists of 33 items evaluating reflex activity, voluntary movement within and out of synergy, wrist and hand function, and coordination/speed. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 indicating optimal motor function. |
Baseline, 3rd week, 6th week
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Muscle Strength Manual Muscle Testing (MMT)
Délai: Baseline, 3rd week, 6th week
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A standardized, performance-based outcome measure assessing muscle strength on a 6-point ordinal scale (0 = no contraction to 5 = normal strength). Evaluates key upper limb muscle groups, including shoulder, elbow, forearm, wrist, and grip bilaterally. Requires no equipment, is clinically feasible, and provides immediate interpretable results. Excellent reliability (ICC = 0.84-0.92) in stroke. |
Baseline, 3rd week, 6th week
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Goniometry
Délai: Baseline, 3rd week, 6th week
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Good-excellent reliability (ICC = 0.90-0.98). A goniometer will be used to assess the range of motion of all joints. A goniometer can assess both active and passive ROM. |
Baseline, 3rd week, 6th week
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Nazish Rafique, DPT, MS-PT NMPT, Ibadat International University
Publications et liens utiles
Publications générales
- Shahid J, Kashif A, Shahid MK. A comprehensive review of physical therapy interventions for stroke rehabilitation: impairment-based approaches and functional goals. Brain Sciences. 2023;13(5):717. Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pakistan Journal of Medical Sciences. 2020;36(7):1435. Baker, R. T., Nasypany, A., Seegmiller, J. G., & Baker, J. G. (2023). Instrument-assisted soft tissue mobilization: A systematic review and meta-analysis of current literature. Journal of Athletic Training, 58(2), 112-125. Cheatham, S. W., Baker, R. T., & Abdenour, T. E. (2021). Instrument-assisted soft tissue mobilization: A clinical commentary. International Journal of Athletic Therapy and Training, 26(4), 187-193. Cuesta-Vargas, A. I., González-Sánchez, M., & Kuisma, R. (2022). Reliability of goniometric measurements in stroke patients: A systematic review. Disability and Rehabilitation, 44(8), 1342-1352. Grefkes, C., & Fink, G. R. (2020). Recovery from stroke: Current concepts and future perspectives. Neurological Research and Practice, 2(1), 17-29. Harb, A., & Kishner, S. (2023). Modified Ashworth Scale. In StatPearls. StatPearls Publishing.
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
- IIUI/RERC/ADT/2026/07/368
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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