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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ghulam Mohiuddin Ghulam Mohiuddin, DPT, MS-PT NPT
- Telefoonnummer: +923323817426
- E-mail: ghulammohiuddinrind@gmail.com
Studie Contact Back-up
- Naam: Nazish Rafique Dr Nazish Rafique, DPT, MS-PT NMPT
- Telefoonnummer: 03002132436
- E-mail: nazish2312@gmail.com
Studie Locaties
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Balochistan
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Quetta, Balochistan, Pakistan
- Werving
- Barkat Medical and Physical-Therapy Center Hazaratown Quetta
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Contact:
- Nazish Rafique, MSPT
- Telefoonnummer: 03002132436
- E-mail: nazish.rafique@uipt.iiui.edu.pk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
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 |
|---|---|
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Experimenteel: 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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Actieve vergelijker: Group B: Conventional Physical Therapy
Conventional Physical Therapy |
45-minute session.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Modified Ashworth Scale (MAS)
Tijdsspanne: Baseline, 3rd week, 6th week
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Nazish Rafique, DPT, MS-PT NMPT, Ibadat International University
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
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
- IIUI/RERC/ADT/2026/07/368
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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