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Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy

2 november 2026 uppdaterad av: Riphah International University

Effectiveness of Structured Telerehabilitation Compared With Clinic-Based Physiotherapy for Improving Gross Motor Functions in Young Children With Spastic Cerebral Palsy

This randomized controlled trial will compare structured telerehabilitation with clinic-based physiotherapy in children aged 4-12 years with spastic cerebral palsy. Both groups will receive physiotherapy three times per week for 12 weeks. The study will evaluate changes in gross motor function using the Gross Motor Function Measure (GMFM-88), assess spasticity using the Modified Ashworth Scale (MAS), and examine the usability of telerehabilitation using the Telehealth Usability Questionnaire (TUQ). The study aims to determine whether structured telerehabilitation can provide an effective alternative to clinic-based physiotherapy while potentially reducing barriers related to travel, cost, and access to pediatric rehabilitation services.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The primary objective of this randomized controlled trial is to compare the effectiveness of structured telerehabilitation and clinic-based physiotherapy in improving gross motor functions among children aged 4-12 years with spastic cerebral palsy classified at Gross Motor Function Classification System (GMFCS) levels I-III. A secondary objective is to assess the usability of structured telerehabilitation using the Telehealth Usability Questionnaire (TUQ). A total of 44 participants will be randomly allocated to two groups, with 22 participants in each group. Both groups will receive physiotherapy three times per week for 12 weeks, with each session lasting approximately 45 minutes. Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), while spasticity will be evaluated using the Modified Ashworth Scale (MAS). Assessments will be conducted at baseline, six weeks, and 12 weeks to monitor changes during the intervention period. The study will determine whether structured telerehabilitation can provide comparable improvements in gross motor function to clinic-based physiotherapy and evaluate its usability as an alternative approach to delivering pediatric rehabilitation services.

Studietyp

Interventionell

Inskrivning (Beräknad)

44

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Pakistan
    • Kpk
      • Swābi, Kpk, Pakistan, 23430
        • Rekrytering
        • Health and wellness physiotherapy and rehabilitation centre shewa adda swabi

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Children aged 4-12 years diagnosed with spastic cerebral palsy.
  2. Children classified at Gross Motor Function Classification System (GMFCS) levels I-III.
  3. Medically stable children able to participate in physiotherapy sessions.
  4. Availability of caregiver support and internet access sufficient to participate in telerehabilitation sessions.
  5. Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

  1. Children without adequate internet access or caregiver support required for telerehabilitation.
  2. Children with uncontrolled seizures or severe comorbidities that interfere with safe participation in physiotherapy.
  3. Children classified at GMFCS levels IV-V.
  4. Children who have undergone orthopedic surgery or received botulinum toxin injections within the preceding 6 months.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Structured Telerehabilitation

Participants will receive a structured physiotherapy program remotely through video communication, three times per week for 12 weeks, with approximately 45 minutes per session.
Beteende: Structured Telerehabilitation Program

A structured physiotherapy program delivered remotely through video communication under physiotherapist guidance, with caregiver assistance. The program will be conducted three times per week for 12 weeks, with each session lasting approximately 45 minutes. Exercises will include stretching, range-of-motion exercises, strengthening, balance training, functional mobility, postural control, and coordination activities tailored to the child's functional abilities.
Aktiv komparator: Clinic-Based Physiotherapy

Participants will receive a structured physiotherapy program in a clinical setting under direct physiotherapist supervision, three times per week for 12 weeks, with approximately 45 minutes per session.
Beteende: Clinic-Based Physiotherapy Program

A structured physiotherapy program delivered in a clinical setting under direct physiotherapist supervision. The program will be conducted three times per week for 12 weeks, with each session lasting approximately 45 minutes. Exercises will include stretching, range-of-motion exercises, strengthening, balance training, functional mobility, postural control, and coordination activities tailored to the child's functional abilities.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Gross Motor Function Measure-88 (GMFM-88) Score
Tidsram: Baseline, 6 weeks, and 12 weeks after the start of the intervention.

Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized tool used to evaluate motor abilities in children with cerebral palsy across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Changes in GMFM-88 scores from baseline to the end of the 12-week intervention will be compared between the structured telerehabilitation and clinic-based physiotherapy groups.
Baseline, 6 weeks, and 12 weeks after the start of the intervention.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Modified Ashworth Scale (MAS) Scores
Tidsram: Baseline and 12 weeks after the start of the intervention.

Spasticity will be assessed using the Modified Ashworth Scale (MAS), which measures resistance to passive movement during clinical examination. Changes in MAS scores from baseline to the end of the intervention will be compared between the two study groups.
Baseline and 12 weeks after the start of the intervention.
Usability of the Structured Telerehabilitation Program
Tidsram: At the end of the 12-week intervention.

The usability of the structured telerehabilitation program will be assessed using the Telehealth Usability Questionnaire (TUQ) at the end of the intervention. The questionnaire will evaluate caregivers' perceptions of the usability and acceptability of the telerehabilitation approach.
At the end of the 12-week intervention.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Riphah International University

Samarbetspartners

Bacha Khan Medical College

Utredare

  • Huvudutredare: Zobia Naeem, MS, Riphah International University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 oktober 2026

Primärt slutförande (Beräknad)

5 april 2027

Avslutad studie (Beräknad)

12 april 2027

Studieregistreringsdatum

Först inskickad

2 november 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Adan Nisar

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