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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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Rekrutierung
        • Shadman Medical Center, Lahore
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Kainat Tariq, MSPTN

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Aktiver 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper Extremity Fugl-Meyer Assessment (UEFMA)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kainat Tariq

Ermittler

  • Hauptermittler: Kainat Tariq, MSPTN, The University of Lahore, Lahore

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

18. Juli 2026

Primärer Abschluss (Geschätzt)

6. September 2026

Studienabschluss (Geschätzt)

6. September 2026

Studienanmeldedaten

Zuerst eingereicht

18. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juli 2026

Zuerst gepostet (Tatsächlich)

22. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • UOL/IREB/25/09/0038

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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