- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ghulam Mohiuddin Ghulam Mohiuddin, DPT, MS-PT NPT
- Telefonnummer: +923323817426
- E-post: ghulammohiuddinrind@gmail.com
Studer Kontakt Backup
- Navn: Nazish Rafique Dr Nazish Rafique, DPT, MS-PT NMPT
- Telefonnummer: 03002132436
- E-post: nazish2312@gmail.com
Studiesteder
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Balochistan
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Quetta, Balochistan, Pakistan
- Rekruttering
- Barkat Medical and Physical-Therapy Center Hazaratown Quetta
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Ta kontakt med:
- Nazish Rafique, MSPT
- Telefonnummer: 03002132436
- E-post: nazish.rafique@uipt.iiui.edu.pk
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: Group B: Conventional Physical Therapy
Conventional Physical Therapy |
45-minute session.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Ashworth Scale (MAS)
Tidsramme: 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)
Tidsramme: Baseline, 3rd week, 6th week
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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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Nazish Rafique, DPT, MS-PT NMPT, Ibadat International University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIUI/RERC/ADT/2026/07/368
Plan for individuelle deltakerdata (IPD)
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