Trial Outcomes & Findings for Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy (NCT NCT01049581)

Results Overview

The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

3 months

Results posted on

2015-02-11

Participant Flow

A convenience sample of 27 children was recruited for the study from the outpatient clinics of the Department of Physical Medicine and Rehabilitation of two tertiary hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.

Exclusion \* Children receiving botulinum toxin injection or surgery within 3 months \* psychiatric diseases or communication disorders \* poorly controlled epilepsy, \* skin problems such as open wound

Participant milestones

Participant milestones
Measure	Pediatric Aquatic Therapy Group \Children diagnosed with cerebral palsy, spastic type,\4 to 12 years of age,\*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference	Conventional Therapy Group \Children diagnosed with cerebral palsy, spastic type,\4 to 12 years of age,\*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
Overall Study STARTED	13	14
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pediatric Aquatic Therapy Group \Children diagnosed with cerebral palsy, spastic type,\4 to 12 years of age,\*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference	Conventional Therapy Group \Children diagnosed with cerebral palsy, spastic type,\4 to 12 years of age,\*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatric Aquatic Therapy Group n=13 Participants The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.	Conventional Therapy Group n=14 Participants The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7 years STANDARD_DEVIATION 3 • n=5 Participants	6 years STANDARD_DEVIATION 2.5 • n=7 Participants	7 years STANDARD_DEVIATION 0.25 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Taiwan	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: complete the study and examination

The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy

Outcome measures

Outcome measures
Measure	Pediatric Aquatic Therapy n=11 Participants 13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study	Conventional Therapy n=13 Participants Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
Unit on Gross Motor Function Measure Scale (GMFM)	5.12 units on a scale Standard Deviation 4.5	2.00 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 months

Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.

Outcome measures

Outcome measures
Measure	Pediatric Aquatic Therapy n=11 Participants 13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study	Conventional Therapy n=13 Participants Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
Daily Living Subscale of Vineland Adaptive Behavior Scale	81.8 units on a scale Standard Deviation 48.9	92.1 units on a scale Standard Deviation 38.5

SECONDARY outcome

Timeframe: 3months

This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation

Outcome measures

Outcome measures
Measure	Pediatric Aquatic Therapy n=11 Participants 13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study	Conventional Therapy n=13 Participants Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children	69.6 units on a scale Standard Error 8.3	68.5 units on a scale Standard Error 14.6

Adverse Events

Effects of Pediatric Aquatic Therapy on Motor Performance

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 Chia- Ling Chen

ChangGungMH

Phone: 886-3-3281200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60