Clinical trial NCT05995197: The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
Official title: The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Exercise Therapy
Keywords: action observation therapy
balance
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: type of study: clinical trial the goal of this study is to learn about action observation therapy for cerebral palsy population.

The main question it aim to answer is:

Is action observation therapy effective on balance in children with cerebral palsy? Twenty-four children who met the inclusion criteria in the study will be randomly divided into two groups as the training group(action observation group) and the control group.

Detailed description: The history and demographic information of all cases will be obtained.Action observation therapy will be applied to improve balance. The therapist will verbally explain the program to be applied to both groups. Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children with CP will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes. The control group will be shown cartoons. After 3 minutes of monitoring, each exercise will be studied for 3 minutes. In order to increase the effectiveness of the action observation training, the participants will watch the video at the designated time in a quiet and noiseless place. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the session will be repeated.

Physiotherapy program to be applied:

First week:

* Double-leg balancing on soft ground with eyes open, hands free
* Balance on both feet on soft ground with eyes closed, hands free
* Stand on one leg with eyes open on hard ground
* Stand on one leg on hard ground with eyes closed

Second week:

* Standing with feet together on hard ground
* Standing in tandem on hard ground
* Right-left lower extremity weight transfer
* Step forward in standing position

Third week:

* Standing with feet together on soft ground
* Standing in tandem on soft ground
* Taking steps in different directions in a standing position
* Kicking the ball with the foot Pre- and post-treatment fNIRS imaging will be used to measure the cerebral cortex blood supply of the participants. The registration will be taken from the fNIRS device (Medical Technologies LLC, Berlin, Germany) using the program NIRStar Acquisition (NIRx Medizintechnik GmbH, Germany). Records will be taken to scan the bilateral supplementary motor area over 8 sources and 4 receivers. NIRS registration will take place during action observation therapy and balance tests. In measuring balance with action observation therapy; Resting in sitting position for 20 seconds, watching action observation video while sitting for 20 seconds, standing on two legs on hard ground for 20 seconds, resting in sitting position for 20 seconds, will be repeated 6 times. For evaluation on soft ground, 20 seconds of resting on both feet with eyes open, 20 seconds of watching action observation video, 20 seconds of standing on two feet with eyes open, 20 seconds of resting on both feet with eyes open will be applied and fNIRS measurement will be performed by repeating 6 times. The same periods will be applied to the control group and a cartoon will be watched instead of the action observation video.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with CP
* To be at I and II levels according to the Gross Motor Function Classification System
* Having bilateral and unilaterally affected spastic type CP
* Cooperating with assessments
* Absence of vision and hearing loss
* According to the health board report, only motor skills are affected

Exclusion Criteria:

* Botulinum toxin application in the last 6 months Having had any surgical operation in the last 6 months
* Having dyskinetic, ataxic and hypotonic type CP
* Not attending treatment sessions regularly for 2 weeks
* Not participating in the pre- and post-treatment evaluation

Primary outcomes:
measure: Pediatric balance scale
timeFrame: 2 days before treatment and after 3 weeks
Secondary outcomes:
measure: Gross motor function classification system
timeFrame: 2 days before treatment
measure: Gross motor function measurement-88
timeFrame: 2 days before treatment and after 3 weeks
measure: Lower Extremity Selective Control Evaluation Scale (SCALE)
timeFrame: 2 days before treatment and after 3 weeks
measure: Trunk Impairment Scale
timeFrame: 2 days before treatment and after 3 weeks
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: 2 days before treatment and after 3 weeks
measure: Nintendo Wii-Fit Balance Score
timeFrame: 2 days before treatment and after 3 weeks
measure: Timed Get Up and Go Test (TUG)
timeFrame: 2 days before treatment and after 3 weeks
measure: Functional Near Infrared Spectroscopy (fNIRS) Application
timeFrame: 2 days before treatment and after 3 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Abdelhaleem N, Taher S, Mahmoud M, Hendawy A, Hamed M, Mortada H, Magdy A, Raafat Ezz El-Din M, Zoukiem I, Elshennawy S. Effect of action observation therapy on motor function in children with cerebral palsy: a systematic review of randomized controlled trials with meta-analysis. Clin Rehabil. 2021 Jan;35(1):51-63. doi: 10.1177/0269215520954345. Epub 2020 Sep 9.
citation: Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
citation: Jung Y, Chung EJ, Chun HL, Lee BH. Effects of whole-body vibration combined with action observation on gross motor function, balance, and gait in children with spastic cerebral palsy: a preliminary study. J Exerc Rehabil. 2020 Jun 30;16(3):249-257. doi: 10.12965/jer.2040136.068. eCollection 2020 Jun.
citation: Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
citation: Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.