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Telerehabilitation for Hand Function in Stroke Patients (TeleStroke-PK)

18 giugno 2026 aggiornato da: Anbreena Rasool, University of Faisalabad

Effects of Conventional Outpatient Rehabilitation With and Without Adjunctive Telerehabilitation on Hand Function and Motor Recovery in Subacute Stroke Patients: A Randomized Controlled Trial

Stroke is a leading cause of adult disability worldwide, with upper limb impairment significantly reducing independence. Traditional outpatient rehabilitation poses challenges for patients with mobility limitations, financial constraints, or those living in remote areas. This randomized controlled trial compares the effects of conventional outpatient rehabilitation with and without adjunctive telerehabilitation on hand function and motor recovery in subacute stroke patients. Forty-eight participants will be randomly assigned to two groups: Group A receives conventional outpatient rehabilitation plus home-based telerehabilitation via WhatsApp video calls (30 minutes daily, 5 days/week for 6 weeks), while Group B receives conventional outpatient rehabilitation alone (same dose and content). Outcome measures include the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Box and Block Test (BBT), and Physical Activity Enjoyment Scale (PACES), assessed at baseline and after 6 weeks.

Panoramica dello studio

Descrizione dettagliata

Stroke persists as the most prevalent cause of disability in adults worldwide, with upper limb disability significantly diminishing the level of independence in stroke survivors. Traditional post-stroke rehabilitation typically requires frequent visits to outpatient facilities, which can be inconvenient for patients with mobility impairments, those facing high transportation costs, or individuals living in remote areas. Telerehabilitation, delivered through digital communication platforms, offers a promising alternative that may expand access to rehabilitation services while maintaining treatment intensity and quality.

This study employs a randomized controlled trial design to investigate whether adding home-based telerehabilitation to conventional outpatient care produces superior outcomes compared to conventional care alone. The study will be conducted at three hospitals in Pakistan: Nusrat Fateh Ali Khan Hospital, Aziz Fatima Trust Hospital, and Madina Teaching Hospital. A total of 48 subacute stroke patients will be enrolled using convenience sampling, with sample size calculated using OpenEpi version 3 based on previous published data (Chen, 2020) with 95% confidence interval and 80% power.

Eligibility Criteria: Participants must have a Fugl-Meyer Assessment for Upper Extremity score between 22-56, a Box and Block Test score of at least 1 block in 60 seconds at screening, and no other major neurological or psychotic diseases, cognitive impairment, or pregnancy.

Randomization and Blinding: Participants will be randomly allocated using a computer-generated sequence. Allocation will be concealed, and outcome assessments will be performed by physiotherapists who remain blinded to group assignment.

Interventions: Both groups receive identical exercise content and dosage. Group A (Experimental) receives conventional outpatient rehabilitation plus home-based telerehabilitation via live WhatsApp video chats supervised by a physiotherapist. Each session lasts 30 minutes, five days per week for six weeks. During video sessions, the therapist observes participant setup, provides online verbal assistance, checks movement quality and safety, and modifies compensatory strategies. Participants receive essential equipment (small objects, balls, TheraBand) and an internet data bundle to support connectivity.

Group B (Control) receives conventional outpatient rehabilitation only, with on-site supervised sessions in neuro-physiotherapy outpatient departments. Sessions are 30 minutes each, five days per week for six weeks, using the same exercise content, dosage, equipment, and repetitions as the telerehabilitation group. A physiotherapist provides direct hands-on supervision, checks accuracy, and adjusts difficulty levels in real-time.

Outcome Measures: Assessments occur at baseline (pre-intervention) and after the 6-week intervention period using: (1) Fugl-Meyer Assessment for Upper Extremity to measure motor recovery; (2) Box and Block Test to measure manual dexterity; and (3) Physical Activity Enjoyment Scale to measure patient enjoyment of physical activity.

Statistical Analysis: Data will be analyzed using SPSS software. Normality testing will precede hypothesis testing to determine appropriate parametric or non-parametric statistical methods. Between-group differences will be analyzed using independent t-tests or Mann-Whitney U tests as appropriate, with significance level set at p < 0.05.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Subacute stroke patients (time since stroke: 1-6 months)\n
  • Fugl-Meyer Assessment for Upper Extremity score between 22-56\n
  • Box and Block Test score of at least 1 block in 60 seconds at the Screening Visit\n
  • Ability to provide informed consent\n
  • Access to a smartphone with WhatsApp capability (for Group A)

Exclusion Criteria:

  • Any other major existing neurological or psychotic disease (e.g., Parkinson's disease, multiple sclerosis)\n
  • Pregnancy\n
  • Any disease apart from index stroke that noticeably affects arm function of paretic limb\n
  • Cognitive impairment that prevents understanding of instructions\n
  • Upper extremity acute orthopedic conditions\n
  • Medically unstable patients

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Telerehabilitation + Conventional Outpatient Rehabilitation
Participants receive conventional outpatient rehabilitation (on-site, 30 min/day, 5 days/week, 6 weeks) PLUS home-based telerehabilitation via WhatsApp video calls (same dose). Therapy includes warm-up/proximal activation exercises (shoulder shrugs, scapular retraction, trunk forward lean), task-oriented and strengthening exercises (reaching tasks, grasp and release, object transfers). Equipment includes small objects, balls, and TheraBand.
Telerehabilitation is delivered via live WhatsApp video chats supervised by a physiotherapist. Each session lasts 30 minutes, five days per week for six weeks. The therapist observes participant setup, provides online verbal assistance, checks movement quality and safety, and modifies compensatory strategies. Participants receive essential equipment (small objects, balls, TheraBand) and an internet data bundle to support connectivity. The therapy protocol is standardized using the Upper Extremity Task Specific Training after Stroke by Lang and Birkenmeier and the Accelerated Skill Attainment Program (Cramer et al., 2019).
Conventional outpatient rehabilitation is delivered on-site at neuro-physiotherapy outpatient departments of participating hospitals. Sessions run 30 minutes each, five days per week for six weeks, using the same exercise content, dosage, and progression criteria as the telerehabilitation group. Exercise components include: warm-up and proximal activation (shoulder shrugs, scapular retraction, trunk forward lean weight bearing) for 5 minutes, followed by task-oriented and strengthening exercises (reaching tasks, grasp and release, transfer of objects) for 20 minutes. A physiotherapist provides direct hands-on supervision, checks movement accuracy, and adjusts difficulty levels in real-time based on participant progress.
Comparatore attivo: Conventional Outpatient Rehabilitation Alone
Participants receive conventional outpatient rehabilitation only (on-site, 30 min/day, 5 days/week, 6 weeks). Therapy content is identical to the experimental group: warm-up/proximal activation exercises, task-oriented and strengthening exercises. A physiotherapist provides direct hands-on supervision, checks accuracy, and adjusts difficulty levels in real time based on participant progress.
Conventional outpatient rehabilitation is delivered on-site at neuro-physiotherapy outpatient departments of participating hospitals. Sessions run 30 minutes each, five days per week for six weeks, using the same exercise content, dosage, and progression criteria as the telerehabilitation group. Exercise components include: warm-up and proximal activation (shoulder shrugs, scapular retraction, trunk forward lean weight bearing) for 5 minutes, followed by task-oriented and strengthening exercises (reaching tasks, grasp and release, transfer of objects) for 20 minutes. A physiotherapist provides direct hands-on supervision, checks movement accuracy, and adjusts difficulty levels in real-time based on participant progress.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Upper Extremity Motor Function
Lasso di tempo: Baseline (pre-intervention) and 6 weeks (post-intervention)
Measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The FMA-UE is a stroke-specific, performance-based impairment index. It assesses motor functioning of the upper extremity. Scores range from 0 to 66, with higher scores indicating better motor function.
Baseline (pre-intervention) and 6 weeks (post-intervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Manual Dexterity
Lasso di tempo: Baseline (pre-intervention) and 6 weeks (post-intervention)
Measured using the Box and Block Test (BBT). The BBT quantifies gross manual dexterity by counting the number of blocks a participant can move from one compartment of a box to another in 60 seconds. Higher scores indicate better manual dexterity.
Baseline (pre-intervention) and 6 weeks (post-intervention)
Change in Physical Activity Enjoyment
Lasso di tempo: Baseline (pre-intervention) and 6 weeks (post-intervention)
Measured using the Physical Activity Enjoyment Scale (PACES). The scale consists of 16 items rated on a 7-point bipolar Likert scale (1 = "I enjoy it" to 7 = "I hate it" for some items, reverse-scored for others). Total scores range from 16 to 112, with higher scores indicating greater enjoyment of physical activity.
Baseline (pre-intervention) and 6 weeks (post-intervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 gennaio 2026

Completamento primario (Stimato)

28 giugno 2026

Completamento dello studio (Stimato)

10 luglio 2026

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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