Trial Outcomes & Findings for RCT on Interactive Computer Play on Trunk Control in CP (NCT NCT02975804)

Results Overview

assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control Children in the control group will continue their usual therapy.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=9 Participants	9 Participants n=9 Participants	18 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Continuous	8.92 years STANDARD_DEVIATION 2.25 • n=9 Participants	9.59 years STANDARD_DEVIATION 1.87 • n=9 Participants	9.26 years STANDARD_DEVIATION 2.04 • n=18 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	3 Participants n=9 Participants	7 Participants n=18 Participants
Sex: Female, Male Male	5 Participants n=9 Participants	6 Participants n=9 Participants	11 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Hong Kong	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants

PRIMARY outcome

Timeframe: 12 weeks

assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Segmental Assessment on Trunk Control-static	8 score on a scale Interval 7.0 to 8.0	8 score on a scale Interval 5.0 to 8.0

PRIMARY outcome

Timeframe: 12 weeks

assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Segmental Assessment on Trunk Control-active	7 score on a scale Interval 5.0 to 8.0	8 score on a scale Interval 4.0 to 8.0

PRIMARY outcome

Timeframe: 12 weeks

assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Segmental Assessment on Trunk Control-reactive	6 score on a scale Interval 4.0 to 8.0	6 score on a scale Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: 12 weeks

assess how far the child can reach forward in sitting

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Pediatric Reach Test-forward Sitting	8.28 centimeters Standard Deviation 74.5	10.72 centimeters Standard Deviation 96.5

SECONDARY outcome

Timeframe: 12 weeks

assess how far the child can reach to his/her right in sitting

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Pediatric Reach Test- Right Sitting	8.5 centimeters Standard Deviation 76.5	10.5 centimeters Standard Deviation 94.5

SECONDARY outcome

Timeframe: 12 weeks

assess how far the child can reach to his/her left in sitting

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Pediatric Reach Test- Left Sitting	8.94 centimeters Standard Deviation 80.50	10.06 centimeters Standard Deviation 90.50

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.

assess how far the child can reach forward in standing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.

assess how far the child can reach to his/her right in standing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.

assess how far the child can reach to his/her left in standing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 \& GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
Gross Motor Function Measure Item Set- Total Score	9.06 score on a scale Standard Deviation 81.5	9.94 score on a scale Standard Deviation 89.5

SECONDARY outcome

Timeframe: 12 weeks

measure how far the study participant can walk in 2 minutes in metres

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school. Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.	Control n=9 Participants Children in the control group will continue their usual therapy.
2-minute Walk Test	8.11 meters Standard Deviation 73.0	10.89 meters Standard Deviation 98.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected in the study as it was determined that measurement of height was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.

measure the height of study participants in centimetres

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected in the study as it was determined that measurement of weight was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.

measure the body weight of study participants in kilograms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.

assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.

assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.

assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.

assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr tamis W Pin

The Hong Kong Polytechnic University

Phone: 85227666751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place