Trial Outcomes & Findings for Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy (NCT NCT01267929)

Results Overview

The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates \< 10% of activity,2=partially completes 10% to \< 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Base line, two months and six months

Results posted on

2017-12-18

Participant Flow

The children were recruited from Thammasat University hospital and Rajanukul institute. Study period was two years which started from September 2009 to October 2011.

Thirty two children were assessed for their eligibility to participate in the study. One were excluded for failing to meet the inclusion criteria. One parent of a child refused to participate in the study.

Participant milestones

Participant milestones
Measure	The Mirror Neurons Stimulation Based VCD Program The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.	The Conventional Physical Therapy The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Mirror Neurons Stimulation Based VCD Program n=15 Participants The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.	The Conventional Physical Therapy n=15 Participants The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.	Total n=30 Participants Total of all reporting groups
Age, Continuous	6.2 years STANDARD_DEVIATION 2.2 • n=5 Participants	5.5 years STANDARD_DEVIATION 2.2 • n=7 Participants	5.9 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Thailand	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Baseline Gross Motor Function Measure (GMFM-66) score	44.8 Scores STANDARD_DEVIATION 14.0 • n=5 Participants	49.4 Scores STANDARD_DEVIATION 13.1 • n=7 Participants	47.1 Scores STANDARD_DEVIATION 13.5 • n=5 Participants

PRIMARY outcome

Timeframe: Base line, two months and six months

Population: A total of 30 children with cerebral palsy was followed and completed the study.

The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates \< 10% of activity,2=partially completes 10% to \< 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.

Outcome measures

Outcome measures
Measure	The Mirror Neurons Stimulation Based VCD Program n=15 Participants The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.	The Conventional Physical Therapy n=15 Participants The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. The mean score of GMFM-66 at the entry	44.8 Scores on a scale Standard Deviation 14.0 • Interval 37.4 to 52.1	49.4 Scores on a scale Standard Deviation 13.1 • Interval 42.5 to 56.3
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. The mean score of GMFM-66 at the second month	54.7 Scores on a scale Standard Deviation 14.5 • Interval 25.2 to 70.2	57.5 Scores on a scale Standard Deviation 16.2 • Interval 31.3 to 80.4
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. The mean score of GMFM-66 at the sixth month	57.8 Scores on a scale Standard Deviation 13.9 • Interval 50.4 to 65.1	63.2 Scores on a scale Standard Deviation 16.8 • Interval 54.3 to 72.1

Adverse Events

The Mirror Neurons Stimulation Based VCD Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Conventional Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miss Namfon Mahasup

Postgraduate Studied Program, faculty of medicine, Thammasat University

Phone: +66 867733596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place