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TELE-REHABILITATION VERSUS CLINIC-BASED MODIFIED CONSTRAINT-INDUCED MOVEMENT THERAPY FOR UPPER LIMB FUNCTION IN CHRONIC STROKE PATIENTS (TELE-mCIMT)

18. juli 2026 opdateret af: Kainat Tariq

Stroke commonly results in persistent upper limb impairment that limits functional independence and participation in daily activities. Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based intervention for improving upper limb function after stroke. Tele-rehabilitation has emerged as an alternative method of delivering rehabilitation services, potentially improving accessibility while maintaining treatment effectiveness.

This randomized controlled trial will compare the effectiveness of tele-rehabilitation-based mCIMT with clinic-based mCIMT in individuals with chronic stroke. Sixty-eight eligible participants will be randomly allocated into two groups. The tele-rehabilitation group will receive supervised mCIMT through virtual sessions combined with a structured home exercise program, while the clinic-based group will receive the same intervention in a clinical setting. Both groups will receive treatment three times per week for 6 weeks.

Upper limb function, spasticity, motor performance, and intrinsic motivation will be assessed at baseline and after the 6-week intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), Wolf Motor Function Test (WMFT), and Intrinsic Motivation Inventory (IMI). The study aims to determine whether tele-rehabilitation is as effective as clinic-based mCIMT for improving upper limb function in individuals with chronic stroke.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a single-center, randomized controlled trial designed to compare the effectiveness of tele-rehabilitation-based modified Constraint-Induced Movement Therapy (mCIMT) with clinic-based mCIMT in individuals with chronic stroke. A total of 68 participants meeting the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and randomly allocated into two groups using the sealed envelope method. Outcome assessors will remain blinded to group allocation.

Participants in the tele-rehabilitation group will attend an initial in-person assessment followed by supervised virtual rehabilitation sessions. The intervention will include heat application, self-stretching, active-assisted range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy. Participants will perform functional upper limb activities while wearing a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.

Participants in the clinic-based group will receive the same rehabilitation components, including heat application, stretching, range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy, delivered face-to-face in the rehabilitation clinic. Treatment sessions will be conducted three times per week for 6 weeks, with home practice using the constraint mitt for 4 hours daily.

Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures will include upper limb motor function assessed using the Upper Extremity Fugl-Meyer Assessment (UEFMA) and spasticity assessed using the Modified Ashworth Scale (MAS). Secondary outcome measures will include the Wolf Motor Function Test (WMFT) and the Intrinsic Motivation Inventory (IMI). The study will evaluate whether tele-rehabilitation-based mCIMT provides comparable or superior improvements in upper limb function, motor performance, spasticity, and motivation compared with clinic-based mCIMT in individuals with chronic stroke.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

68

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Rekruttering
        • Shadman Medical Center, Lahore
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kainat Tariq, MSPTN

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Participant with age from 35 to 75 years
  • Both gender
  • Patients after 6 month of stroke.
  • Participant with flexion and abduction at shoulder minimum 10-15 degree and 5-10 degree at wrist and thumb/digit.
  • Participants with access to a smartphone or laptop with internet connectivity and the ability to use it for tele-rehabilitation sessions.
  • Participant with modified ashworth scale score of 2 or higher.
  • Participants who have internet access and can also engage in video conferences.

Exclusion Criteria:

  • Patient with any neurological issues apart from stroke that might impact motor function.
  • Patient who is not able to follow the commands or are unable to cooperate.
  • Patient with any autoimmune disorder like rheumatoid arthritis that might impact arm function.
  • Patient with history of epilepsy. Participant who are involved in any fitness program that can improve upper extremity function.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation. The intervention will include supervised virtual sessions consisting of heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities. Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home. Treatment will be provided 3 sessions per week for 6 weeks.
Adfærdsmæssigt: Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation. The intervention will include supervised virtual sessions comprising heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities. Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home. Treatment will be delivered 3 sessions per week for 6 weeks.
Aktiv komparator: group B Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting. The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision. Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and for 4 hours daily at home. Treatment will be provided 3 sessions per week for 6 weeks.
Adfærdsmæssigt: Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting. The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision. Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and continue constraint use for 4 hours daily at home. Treatment will be delivered 3 sessions per week for 6 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Upper Extremity Fugl-Meyer Assessment (UEFMA)
Tidsramme: Baseline and Week 6
The Upper Extremity Fugl-Meyer Assessment (UEFMA) will be used to evaluate upper limb motor recovery. Changes in UEFMA scores from baseline to the end of the 6-week intervention will be compared between the tele-rehabilitation and clinic-based modified Constraint-Induced Movement Therapy groups.
Baseline and Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kainat Tariq

Efterforskere

  • Ledende efterforsker: Kainat Tariq, MSPTN, The University of Lahore, Lahore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

18. juli 2026

Primær færdiggørelse (Anslået)

6. september 2026

Studieafslutning (Anslået)

6. september 2026

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • UOL/IREB/25/09/0038

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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