Spastic Cerebral Palsy
Conditions
Keywords
Gross motor function performance, pediatric aquatic therapy, spastic cerebral palsy
Brief summary
Aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for children with cerebral palsy to evaluate the effect of hydrotherapy. Purpose: To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and social participation in children with spastic cerebral palsy. Method: The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These children were dived into two groups: traditional rehabilitation therapy (control group), and hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily activity and social participation before and after the intervention and compared the difference in improvement between groups. The measurements include modified Ashworth score, Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL). Expect effect: We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity.Children could improve self-esteem and we hypothesize this could improve social participation.
Detailed description
* We conducted a well-designed study to investigate the effectiveness of PAT on motor function, activities of daily living (ADL),and health related quality of life(HRQOL) perspectives for children with CP. * 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. * The study was designed as a single blinded, prospective, case control study. * The pediatric aquatic therapy group got more improvementon motor performance measured by GMFM-66.
Interventions
PROCEDUREaquatic therapy
two hours per week, one hour per time, total 12 weeks
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children diagnosed as cerebral palsy, spastic type 2. Gross Motor Functional Classification (GMFCS) level II-IV 3. Age: 4-12 y/o 4. Informed consent by parents 5. Modified Ashworth score 2 or3 6. If participant history of epilepsy ,well controlled by medication
Exclusion criteria
1. History of psychiatric diseases 2. Poor controlled epilepsy 3. Received botox injection or surgery in recent three months 4. Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism 5. Severe mental retardation 6. Active infection (Body temperature \> 100°F) 7. Communication problems 8. Bowel incontinence 9. Bladder incontinence 10. Severe cardiovascular disease 11. Infectious skin conditions and open wound 12. Nasogastric tubes or gastrostomy tubes 13. Colostomy ,urostomy or ileostomy bags 14. Acute orthopedic injury with pain and instability 15. Diabetes 16. Chlorine sensitivity 17. Latex allergies 18. Tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unit on Gross Motor Function Measure Scale (GMFM) | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Living Subscale of Vineland Adaptive Behavior Scale | 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. |
| Subscale on Cerebral Palsy Quality of Life Questionnaire for Children | 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 |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Aquatic Therapy Group 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. | 13 |
| Conventional Therapy Group 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. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Conventional Therapy Group | Pediatric Aquatic Therapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6 years STANDARD_DEVIATION 2.5 | 7 years STANDARD_DEVIATION 3 | 7 years STANDARD_DEVIATION 0.25 |
| Region of Enrollment Taiwan | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Unit on Gross Motor Function Measure Scale (GMFM)
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
Time frame: 3 months
Population: complete the study and examination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Aquatic Therapy | Unit on Gross Motor Function Measure Scale (GMFM) | 5.12 units on a scale | Standard Deviation 4.5 |
| Conventional Therapy | Unit on Gross Motor Function Measure Scale (GMFM) | 2.00 units on a scale | Standard Deviation 2.7 |
Comparison: null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy groupp-value: 0.007ANCOVA
Secondary
Daily Living Subscale of Vineland Adaptive Behavior Scale
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Aquatic Therapy | Daily Living Subscale of Vineland Adaptive Behavior Scale | 81.8 units on a scale | Standard Deviation 48.9 |
| Conventional Therapy | Daily Living Subscale of Vineland Adaptive Behavior Scale | 92.1 units on a scale | Standard Deviation 38.5 |
Comparison: We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADLp-value: 0.393ANCOVA
Secondary
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
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
Time frame: 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Aquatic Therapy | Subscale on Cerebral Palsy Quality of Life Questionnaire for Children | 69.6 units on a scale | Standard Error 8.3 |
| Conventional Therapy | Subscale on Cerebral Palsy Quality of Life Questionnaire for Children | 68.5 units on a scale | Standard Error 14.6 |
Comparison: null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy groupp-value: 0.332ANCOVA