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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.

8. november 2026 oppdatert av: Ibadat International University, Islamabad

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

Studietype

Intervensjonell

Registrering (Antatt)

46

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Nazish Rafique Dr Nazish Rafique, DPT, MS-PT NMPT
  • Telefonnummer: 03002132436
  • E-post: nazish2312@gmail.com

Studiesteder

    • Balochistan
      • Quetta, Balochistan, Pakistan
        • Rekruttering
        • Barkat Medical and Physical-Therapy Center Hazaratown Quetta
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
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

  • Technique: Multidirectional strokes at 30-60 second intervals
  • Intensity: Moderate pressure causing mild erythema without bruising
  • Frequency: 3 sessions/week for 6 weeks
  • Conservative Physical Therapy: 45-minute session including
  • Passive stretching of spastic muscles (15 min)
  • Active-assisted ROM exercises (10 min)
  • Strengthening exercises (10 min) - including isometric holds, concentric/eccentric contractions as tolerated
  • Task-oriented Training of upper limb, {Reaching activities, Grasping & releasing objects, Object manipulation tasks (stacking blocks, turning objects), Simulated ADL tasks (feeding, grooming) (10 min)}
Aktiv komparator: Group B: Conventional Physical Therapy

Conventional Physical Therapy

45-minute session.

  • Passive stretching of spastic muscles (15 min)
  • Active-assisted ROM exercises (10 min)
  • Strengthening exercises (10 min)-including isometric holds and concentric/eccentric contractions as tolerated
  • Task-oriented Training of upper limb, {Reaching activities, Grasping & releasing objects, Object manipulation tasks (stacking blocks, turning objects), Simulated ADL tasks (feeding, grooming)} (10 min)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Modified Ashworth Scale (MAS)
Tidsramme: 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
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Tidsramme: 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
Muscle Strength Manual Muscle Testing (MMT)
Tidsramme: Baseline, 3rd week, 6th week

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
Goniometry
Tidsramme: Baseline, 3rd week, 6th week

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Nazish Rafique, DPT, MS-PT NMPT, Ibadat International University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. juli 2026

Primær fullføring (Antatt)

15. november 2026

Studiet fullført (Antatt)

30. november 2026

Datoer for studieregistrering

Først innsendt

8. november 2026

Først innsendt som oppfylte QC-kriteriene

8. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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