The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy

Sponsor
Medipol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05995197
Collaborator
(none)
24
2
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: action observation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: action observation therapy group

Children will watch the action observation therapy 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 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.In order to increase the effectiveness of the action observation training. 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 treatment will be repeated.

Other: action observation
cartoon observation

No Intervention: control group

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. The therapist will explain the exercises verbally. Children will practice the exercise after watching cartoons. The watching time for each exercise is 3 minutes, and after watching 3 minutes of cartoons, they will do the exercise for 3 minutes. 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, pre-treatment evaluations will be repeated.

Outcome Measures

Primary Outcome Measures

  1. Pediatric balance scale [2 days before treatment and after 3 weeks]

    The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.

Secondary Outcome Measures

  1. Gross motor function classification system [2 days before treatment]

    The Gross Motor Function Classification System (KMFSS) for CP is based on self-initiated movements with an emphasis on sitting, displacement and mobility. The main criterion when defining the five-level classification system is that the differences between the levels are meaningful in everyday life. General titles of each level LEVEL I: Walks without restrictions. LEVEL II: Walks with restrictions. LEVEL III: Walks using hand-held mobility devices. LEVEL IV: Self-movement is limited. Can use a motorized mobility vehicle. LEVEL V: Transported in a manual wheelchair.

  2. Gross motor function measurement-88 [2 days before treatment and after 3 weeks]

    Gross Motor Function Scale (GMFM-88) is divided into 5 main sections. It consists of a total of 88 items, 17 in the supine-prone position and turning section, 20 in the sitting section, 14 in the crawling-over-knee section, 13 in the standing section, and 24 in the walking-running-stair climbing section.

  3. Lower Extremity Selective Control Evaluation Scale (SCALE) [2 days before treatment and after 3 weeks]

    The evaluation method currently used in the evaluation of selective motor control of the lower extremity is SCALE. Hip, knee, ankle, subtalar joint and toes bilaterally; It scores between 0-2 points.

  4. Trunk Impairment Scale [2 days before treatment and after 3 weeks]

    The trunk impairment scale evaluates the trunk functionally in terms of strength in sitting position. The trunk impairment scale consists of three subsections: static, dynamic and coordination. The highest scores that can be obtained from the static, dynamic and coordination sub-headings are respectively; 7, 10 and 6 points. The total scale score ranges from 0 to 23.

  5. Pediatric Outcome Data Collection Instrument (PODCI) [2 days before treatment and after 3 weeks]

    PODCI is one of the scales with proven validity and reliability, which is prepared for both children and adolescents, and is frequently used to determine functional status and evaluate health-related quality of life. The scale has 3 different forms; PODCI child form: The section consisting of 86 questions is filled by the families of children aged 6-10. PODCI adolescent family form: The section consisting of 86 questions is filled by the families of adolescents aged 11-18. PODCI adolescent form: The section consisting of 83 questions is filled by adolescents between the ages of 11-18. As a result, subscale standardized score "0" indicates worse health status and quality of life, "100" score indicates good health status and quality of life.

  6. Nintendo Wii-Fit Balance Score [2 days before treatment and after 3 weeks]

    After the demographic information of the patient is saved in the device system, the patient is shown how to place his/her foot on the Nintendo Wii Fit balance board, the weight ratio given to the right and left feet (Body Center of Gravity right and left) is evaluated by asking him to stand on the balance board without moving, and the data is recorded as a percentage.

  7. Timed Get Up and Go Test (TUG) [2 days before treatment and after 3 weeks]

    It is a valid and reliable method used to evaluate functional mobility and static and dynamic balance in CP. From a starting position with hips, knees, and ankles flexed to 90°, participants get up from a chair without arm support, walk 3 meters, return and sit in the chair. The time starts to be recorded with the "go" prompt given by the evaluator and is stopped when the hip touches the chair.

  8. Functional Near Infrared Spectroscopy (fNIRS) Application [2 days before treatment and after 3 weeks]

    fNIRS is one of the new methods used in the measurement of local cerebral blood flow. It provides information about brain activity in the measured region using optical scattering and absorption of light at wavelengths close to infrared (700-950 nm).

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
melike özipek, physiotherapist, Medipol University
ClinicalTrials.gov Identifier:
NCT05995197
Other Study ID Numbers:
  • MedipolUmelikeözipek
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by melike özipek, physiotherapist, Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023