NCT04896840

Brief Summary

The investigators study aimed to observe the effect of motor learning-based tele-rehabilitation on quality of life in children with cerebral palsy during the Covid-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

May 14, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pediatric Quality of Life Inventory

    The 35-item PedsQL consists of seven subscales: Daily Activities, School Activities, Movement and Balance, Pain, Fatigue, Eating Activities, Speaking and Communication. The scale consists of a child self-report and a parent report. The scale questions the degree of problems the children have experienced in the last month. Item scores are converted linearly backwards on a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so higher scores indicate better health-related quality of Life.Subscale scores are calculated by dividing the total score of the items answered by the number of items answered. There is no scale total score, subscales have calculated mean scores. The higher the average score for an area (subscale) indicates that there are fewer problems in that area and the higher the quality of life.

    8 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Telerehabilitation and motor learning principles will be applied.

Other: Telerehabilitation İntervention, Motor learning

Control Group

EXPERIMENTAL

Motor learning principles will be applied in the clinic.

Other: Telerehabilitation İntervention, Motor learning

Interventions

Telerehabilitation İntervention: Training videos will be sent to the families of the children in the tele-rehabilitation group before starting to work. With the training videos, it is aimed to teach the exercises to be done to the families. Treatment will be applied by their families for 8 weeks, 2 days a week, 40 minutes a day. Physiotherapist will attend the sessions by video conference method. Video conference calls will be made by phone over the WhatsApp application. Motor learning: The first 10 minutes will start with active stretching Functional lying in a sitting position, Functional lying with feet together in a standing position. rolling the pilates ball on the wall, walking on its side. Going up and down stairs at different heights. Walking across different surfaces and obstacles. Getting up from chairs of different heights, sitting and extending the object taken from the ground. Functional exercises suitable for the child's level.

Control GroupTreatment group

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with spastic cerebral palsy, ages 3-16
  • To be at 1-2-3 levels according to GMFCS
  • The tele-rehabilitation group is not receiving treatment in any center.
  • Voluntary participation in the study with the consent of the parents

You may not qualify if:

  • Application of muscle tone reduction 6 months before the start of the study (eg botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inonu University

Malatya, 44000, Turkey (Türkiye)

RECRUITING

Inonu University

Malatya, 44000, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Bar-Haim S, Harries N, Nammourah I, Oraibi S, Malhees W, Loeppky J, Perkins NJ, Belokopytov M, Kaplanski J, Lahat E; MERC project. Effectiveness of motor learning coaching in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 2010 Nov;24(11):1009-20. doi: 10.1177/0269215510371428. Epub 2010 Jun 24.

    PMID: 20576667BACKGROUND
  • Dunn AM, Patel KP. Integration of geriatric with general medical services. Lancet. 1983 Nov 12;2(8359):1139. doi: 10.1016/s0140-6736(83)90650-5. No abstract available.

    PMID: 6138665BACKGROUND
  • Meijer HA, Graafland M, Goslings JC, Schijven MP. Systematic Review on the Effects of Serious Games and Wearable Technology Used in Rehabilitation of Patients With Traumatic Bone and Soft Tissue Injuries. Arch Phys Med Rehabil. 2018 Sep;99(9):1890-1899. doi: 10.1016/j.apmr.2017.10.018. Epub 2017 Nov 11.

    PMID: 29138050BACKGROUND
  • Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.

    PMID: 28455277BACKGROUND
  • Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.

    PMID: 16097489BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 21, 2021

Study Start

August 27, 2021

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

The information of the patients participating in the study will be kept confidential.

Locations