Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Zahoor Dr. Zahoor Ahmed, Phd
- Telefoonnummer: +92 315 6767569
- E-mail: Zahoor_riphah@hotmail.com
Studie Locaties
-
-
Kpk
-
Swābi, Kpk, Pakistan, 23430
- Werving
- Health and wellness physiotherapy and rehabilitation centre shewa adda swabi
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Children aged 4-12 years diagnosed with spastic cerebral palsy.
- Children classified at Gross Motor Function Classification System (GMFCS) levels I-III.
- Medically stable children able to participate in physiotherapy sessions.
- Availability of caregiver support and internet access sufficient to participate in telerehabilitation sessions.
- Written informed consent provided by a parent or legal guardian.
Exclusion Criteria:
- Children without adequate internet access or caregiver support required for telerehabilitation.
- Children with uncontrolled seizures or severe comorbidities that interfere with safe participation in physiotherapy.
- Children classified at GMFCS levels IV-V.
- Children who have undergone orthopedic surgery or received botulinum toxin injections within the preceding 6 months.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
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. |
|
Actieve vergelijker: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Gross Motor Function Measure-88 (GMFM-88) Score
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Modified Ashworth Scale (MAS) Scores
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Zobia Naeem, MS, Riphah International University
Publicaties en nuttige links
Algemene publicaties
- Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- Morgan C, Fetters L, Adde L, Badawi N, Bancale A, Boyd RN, Chorna O, Cioni G, Damiano DL, Darrah J, de Vries LS, Dusing S, Einspieler C, Eliasson AC, Ferriero D, Fehlings D, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Mak C, Maitre N, McIntyre S, Mei C, Morgan A, Kakooza-Mwesige A, Romeo DM, Sanchez K, Spittle A, Shepherd R, Thornton M, Valentine J, Ward R, Whittingham K, Zamany A, Novak I. Early Intervention for Children Aged 0 to 2 Years With or at High Risk of Cerebral Palsy: International Clinical Practice Guideline Based on Systematic Reviews. JAMA Pediatr. 2021 Aug 1;175(8):846-858. doi: 10.1001/jamapediatrics.2021.0878.
- Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
- İlhanlı M, İlhanlı İ, Çelenk P. Cerebral palsy and oral health. Deneysel ve Klinik Tıp Dergisi. 2022;39(4):1283-93.
- Gong C, Liu X, Fang L, Liu A, Lian B, Qi X, Chen S, Li H, Zhao M, Guo J, Zhou S. Prevalence of cerebral palsy comorbidities in China: a systematic review and meta-analysis. Front Neurol. 2023 Sep 28;14:1233700. doi: 10.3389/fneur.2023.1233700. eCollection 2023.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Adan Nisar
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .