Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic Training
Conventional Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Aerobic Training, Gross Motor Function, Stationary Cycle, Diplegic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- 6-12 years of age both genders will be included.
- Ability to follow simple verbal instructions.
- Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system [gmfcs] levels i-iii)
- Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2
Exclusion Criteria:
- Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
- Botulinum toxin injections within the preceding 3 months
- Serial casting or new orthotic devices within the preceding 3 months
- Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
- Inability or unwillingness to maintain age appropriate behavior
- Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
- Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle
Sites / Locations
- Physiogic Physiotherapy Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic Training Group
Conventional Physiotherapy
Arm Description
Cycling exercise group along with Conventional therapy
Strectching with ROM and gait training
Outcomes
Primary Outcome Measures
Gross Motor Function Measure (GMFM-66)
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. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT).
Modified Ashworth Scale (MAS)
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good reliability and validity
Secondary Outcome Measures
Full Information
NCT ID
NCT05321797
First Posted
April 2, 2022
Last Updated
June 27, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05321797
Brief Title
Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy
Official Title
Effects Of Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Aerobic Training, Gross Motor Function, Stationary Cycle, Diplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Training Group
Arm Type
Experimental
Arm Description
Cycling exercise group along with Conventional therapy
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
Strectching with ROM and gait training
Intervention Type
Other
Intervention Name(s)
Aerobic Training
Intervention Description
This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM-66)
Description
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. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT).
Time Frame
8th Week
Title
Modified Ashworth Scale (MAS)
Description
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good reliability and validity
Time Frame
8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
6-12 years of age both genders will be included.
Ability to follow simple verbal instructions.
Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system [gmfcs] levels i-iii)
Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2
Exclusion Criteria:
Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
Botulinum toxin injections within the preceding 3 months
Serial casting or new orthotic devices within the preceding 3 months
Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
Inability or unwillingness to maintain age appropriate behavior
Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiogic Physiotherapy Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
64000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28691601
Citation
Damiano DL, Stanley CJ, Ohlrich L, Alter KE. Task-Specific and Functional Effects of Speed-Focused Elliptical or Motor-Assisted Cycle Training in Children With Bilateral Cerebral Palsy: Randomized Clinical Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):736-745. doi: 10.1177/1545968317718631. Epub 2017 Jul 8.
Results Reference
background
PubMed Identifier
20093327
Citation
Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.
Results Reference
background
PubMed Identifier
33519075
Citation
Fujimoto J, Umemoto Y, Koike Y, Isida K, Sakamoto K, Tajima F. Immediate effects of short period lower limb ergometer exercise in adolescent and young adult patients with cerebral palsy and spastic diplegia. J Phys Ther Sci. 2021 Jan;33(1):52-56. doi: 10.1589/jpts.33.52. Epub 2021 Jan 5.
Results Reference
background
PubMed Identifier
33386826
Citation
da Rosa Pinheiro DR, Cabeleira MEP, da Campo LA, Correa PS, Blauth AHEG, Cechetti F. Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial. NeuroRehabilitation. 2021;48(1):39-47. doi: 10.3233/NRE-201585.
Results Reference
background
Citation
El-Tamawy MS, Darwish MH, Basheer MA, Reda AM, Elzanaty M, Khalifa HA. Effect of cycling exercise on motor excitability and gait abnormalities in stroke patients. The Egyptian Journal of Neurology, Psychiatry and Neurosurgery. 2021;57(1):1-7
Results Reference
background
PubMed Identifier
30935240
Citation
Armstrong EL, Spencer S, Kentish MJ, Horan SA, Carty CP, Boyd RN. Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Clin Rehabil. 2019 Jul;33(7):1113-1129. doi: 10.1177/0269215519837582. Epub 2019 Apr 2.
Results Reference
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Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy
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