Effectiveness of Wearable Trackers and Telerehabilitation in Cerebral Palsy

NCT06800014 | Completed

• 1 other identifier: 2024/02-29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. As a result, it is well known that daily life often hinders the implementation of prescribed home programmes, leading to neglect. In the rehabilitation of people with cerebral palsy, physiotherapists face difficulties in monitoring patients and ensuring compliance with home exercise programmes. Both people with cerebral palsy and their carers often experience dissatisfaction and lack of motivation regarding the monitoring and control of development and activity. This study aims to evaluate the effectiveness of a telerehabilitation programme supported by a mobile application and a wearable activity tracker, in addition to a standard rehabilitation programme, on physical activity levels, quality of life, sleep quality, balance, activity participation and motivation, and patient satisfaction in people with cerebral palsy.

Conditions

Cerebral Palsy (CP); Telerehabilitation; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Physical Activity Questionnaire for Adolescents

  The PAQ-A was developed by Kowalski et al. in 1997 to assess physical activity levels in adolescents (Kowalski et al., 2004). It is suitable for the 14-20 age group. The questionnaire consists of nine questions and assesses physical activity levels over the past seven days. The Turkish validity and reliability study was conducted in 2017. PAQ-A contains eight questions scored between 1 and 5, with a ninth question asking about any condition that might have prevented physical activity during the past week. A score of "1" indicates low-intensity physical activity, while "5" indicates high-intensity physical activity. The ninth question is not included in the scoring. The total score is calculated by averaging the scores of all questions (Aygün Polat, 2017).

  Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

• Physical Activity Enjoyment Scale

  The PAES is a satisfaction scale developed by Mullen et al., consisting of eight items rated on a 7-point Likert scale (Mullen, 2011). The Turkish validity and reliability study was conducted by Bozkurt et al. (Bozkurt et al., 2022).

  Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

Secondary Outcomes (3)

• Cerebral Palsy Quality of Life Questionnaire for Teen

  Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

• Pittsburgh Sleep Quality Index

  Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

• Trunk Control Measurement Scale

  Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Other: Telerehabilitation

Control

EXPERIMENTAL

Other: Conventional exercise

Interventions

Telerehabilitation OTHER

Participants in the telerehabilitation group will receive weekly home exercise instructions through a mobile application installed on their or their caregivers' smartphones, in addition to their standard rehabilitation program. These instructions will include videos, reminders, and directives for the exercises, with compliance monitored through mini-surveys delivered via the app.

Telerehabilitation

Conventional exercise OTHER

Participants in the conventional exercise group will continue their standard rehabilitation program supplemented with printed home exercise instructions, including visuals and text, similar to the content provided to the TG.

Control

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 14 and 18 years old
• Diagnosed with cerebral palsy
• Currently enrolled in a regular rehabilitation programme
• Level 1-3 according to Gross Motor Function Classification System (GMFCS)
• No cognitive impairments affecting the understanding of exercise programmes
• Voluntary informed consent to participate
• No recent surgeries (e.g. botox, muscle relaxation) within the past 6 months
• No socioeconomic issues related to the use of smart devices

You may not qualify if:

• The impact of recent surgical procedures or medical interventions on physical performance.
• The influence of health conditions that affect the entire body and physical performance.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 7, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)