- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06966076
- Original Trial
Effect of Callisthenic Training on Mobility and ADL Performance in Spastic Diplegic Cerebral Palsy Patients
Almost 2 to 3 out of every 1000 children have Cerebral palsy in Pakistan.Spastic type of CP is dominant about 75%, diplegia (40%) and hemiplegic are (35.5%).Spastic diplegics have tightness of lower limb more than upper limb.Their chief complaints are reduced mobility,impaired balance and coordination and lack of postural control and stability.Calisthenic training is sort of strengthening exercises in which patient use his/her own body weight as a resistance.
Calisthenic training aims to reduce movement limitation,contracture formation and improves patient's mobility for daily transfers and ambulation,active participation of patient in indoor and outdoor activities and enhance postural stability and controle during routine tasks. The current study aims to determine the effects of calisthenic training on mobility and ADL performance in spastic diplegic cerebral palsy children aged 5-12 years fulfilling the GMFCS criteria levels 1-3. A randomized control trial will be conducted in multidisciplinary lab of FUCP, department of physical medicine and peads and rehabilitation of Fauji Foundation Hospital on the sample of 32 participants. The subjects will be randomized into two groups by sealed opaque envelope method. Baseline assessment would be done by using WEEFIM measurement assessment scale for mobility and ADL performance, pediatric balance assessment Scale for postural control. Data will be collected at baseline before intervention, after 3 weeks and finally after 6 weeks of intervention. Interventional group will be receiving calisthenic training and conventional physical therapy while control group will be receiving conventional physical therapy alone. Exercise training would be done for a total of 12 sessions for 6 weeks, twice a week with each session lasting 45 minutes. Analysis would be done by using SPSS version 21. Ethical approval will be obtained from ERC of FUSH. Informed written consent will be obtained from all participants.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES OF STUDY
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on mobility, ADL perfrmance and quality of life in spastic diplegic cp children .
- To determine the affects of callisthenic exercises in comparison to conventional physical therapy on postural controle in spastic diplegic cp
HYPOTHESIS:
Alternate hypothesis:
- affect of calisthenic training in comparison to conventional physical therapy on mobility in spastic diplegic cp patients (p<0.05).
- 2HA- There will be statistically significant difference in the affect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
- 3HA- There will be statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
NULL HYPOTHESIS
- 1H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve ADL performance in spastic diplegic cp patients (p<0.05).
2H0 -There will be no statistically significant difference in the effect of calisthenic training in comparison to conventional physical therapy to improve mobility in spastic diplegic cp patients (p<0.05).
3H0 -There will be no statistically significant difference in the effect of calisthenic trainingin comparison to conventional physical therapy to improve postural controle in spastic diplegic cp patients (p<0.05).
Significanve of study:
As there is no any Conclusive evidence of calisthenic training more precisely for spastic diplegic cp children so this study will be helpful for patients and other health care proffessionals to implement this study in their clinical practice and for the patients in a way they can keep continue this treatment protocol in their home bound friendly environment by using their own body weights as a resistance after quiting from sessions of this research .
it will provide a treatment protocol for targeting calisthenic training to improve mobility, incorporate postural corrections and functional capacitance in spastic cp children .
This study will maximize the indoor functional independency in the cerebral palsy
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Foundation University College of Physical Thrapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 5 and 13 years
- Able to accept and follow verbal instructions
- Able to participate in a training program
- Based on Gross Motor Function Classification System (GMFCS SCALE 1,2 and 3)
Exclusion Criteria:
- If they have controlled seizures
- If they suffered from any inflammatory, infectious diseases, cognitive deficiencies and any musculoskeletal deformity with chronic contracture that interfere with physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: calisthenic training group
CALISTHENIC TRAINING CALISTHENIC EXERCISES COMMAND AND TARGET MUSCLE GROUP
|
COMMAND AND TARGET MUSCLE GROUP
|
|
Experimental: conventional physical therapy group
CONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting |
CONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mobility
Time Frame: 8 weeks
|
The WeeFIM was used, it is an 18-item, 7-level ordinal scale.
Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).
|
8 weeks
|
|
Activities of Daily Living Performance
Time Frame: 8 weeks
|
Will be measured by weefim functional independence measure scale. It is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest). |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural control
Time Frame: 8 weeks
|
Will be assessed by paediatric assessment scale It has 14 items and 5 level scale.1 indicating complete dependence and 5 indicating complete independence total score are 56.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/70
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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