- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07666906
Telerehabilitation for Hand Function in Stroke Patients (TeleStroke-PK)
Effects of Conventional Outpatient Rehabilitation With and Without Adjunctive Telerehabilitation on Hand Function and Motor Recovery in Subacute Stroke Patients: A Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pákistán, 3800
- The University of Faisalabad
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Upper Extremity Motor Function
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Manual Dexterity
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Neurologické projevy
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Mrtvice
- Paréza
- Správa zdravotnických služeb
- Poskytování zdravotní péče
- Terapeutika
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Telemedicína
- Řízení péče o pacienty
- Telerehabilitace
Další identifikační čísla studie
- TUF/EIRB/ 200 /26
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .