Effects of Ankle Mobilization on Body Structure, Function, Activities and Participation of Children With Cerebral Palsy
Primary Purpose
Diplegic Cerebral Palsy With Spasticity
Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Diplegic Cerebral Palsy With Spasticity
Eligibility Criteria
Inclusion Criteria:
- Spastic Diplegic CP
- healthy bones appropriate for mobilisation
- ages between 4-14
- GMFCS I, II
- Ashworth scale 2-3 (For Gastrocnemius Muscle)
- Good cognitive ability to understand the orders in the tests
- CP children who continued to take regular physiotherapy sessions
Exclusion Criteria:
- Recent correcting orthopaedic surgeries until 6 months before recruitment
- Children received or intending to receive Botox within an interval of 3 months
- Children who have full Ankle dorsal flexion.
- fixed contracture
Sites / Locations
- Palestine Ahliya university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention group
Control group
Arm Description
5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging
5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging
Outcomes
Primary Outcome Measures
Change of Ankle Range of Motion
ROM of Ankle Dorsiflexion passively and actively will be done using goniometer to assess any changes.
Change in the Six minutes walking test: The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
For measuring the changes in walking activities.The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Change inTime up and go (TUG) test: The TUG test is a reliable and responsive measure of balance and mobility for children with CP
For assessing the change in Balance and mobility
Change in the Pediatric Quality of Life: it is measured by measure by CP-specific questionnaire. We will use The Arabic-CP-QOL-questionnaire
To assess the change in the quality of life and happiness of the children
Change in the Gross Motor Function Measure (GMFM) scale which is designed to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
To assess the changes in the Functional performance in thegross motor function of Cerebral Palsy children
Secondary Outcome Measures
Full Information
NCT ID
NCT05500924
First Posted
August 4, 2022
Last Updated
January 11, 2023
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT05500924
Brief Title
Effects of Ankle Mobilization on Body Structure, Function, Activities and Participation of Children With Cerebral Palsy
Official Title
The Effects of Ankle Mulligan Mobilization on Range of Motion, Balance, Functional Performance and Quality of Life of Children With Diplegic Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Detailed Description
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Research questions What is the effect of Ankle MWM in functional activities on gait function ? What is the effect of Ankle MWM in functional activities on balance function ? What is the effect of Ankle MWM in functional activities on quality of life? What is the effect of Ankle MWM in functional activities on fatigue?
Research hypothesis Ankle MWM in functional activities improves gait function? Ankle MWM in functional activities improve balance? Ankle MWM in functional activities improves quality of life? Ankle MWM in functional activities increase happiness? Research objectives To investigate the effect of Ankle MWM in functional activities on gait function? To study the effect of Ankle MWM in functional activities on balance function? To highlight the effect of Ankle MWM in functional activities on quality of life? To study the effect of Ankle MWM in functional activities on happiness?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy With Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging
Arm Title
Control group
Arm Type
Experimental
Arm Description
5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging
Primary Outcome Measure Information:
Title
Change of Ankle Range of Motion
Description
ROM of Ankle Dorsiflexion passively and actively will be done using goniometer to assess any changes.
Time Frame
Baseline and post 4 weeks assessment
Title
Change in the Six minutes walking test: The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Description
For measuring the changes in walking activities.The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Time Frame
Baseline and post 4 weeks assessment
Title
Change inTime up and go (TUG) test: The TUG test is a reliable and responsive measure of balance and mobility for children with CP
Description
For assessing the change in Balance and mobility
Time Frame
Baseline and post 4 weeks assessment
Title
Change in the Pediatric Quality of Life: it is measured by measure by CP-specific questionnaire. We will use The Arabic-CP-QOL-questionnaire
Description
To assess the change in the quality of life and happiness of the children
Time Frame
Baseline and post 4 weeks assessment
Title
Change in the Gross Motor Function Measure (GMFM) scale which is designed to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
Description
To assess the changes in the Functional performance in thegross motor function of Cerebral Palsy children
Time Frame
Baseline and post 4 weeks assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Spastic Diplegic CP
healthy bones appropriate for mobilisation
ages between 4-14
GMFCS I, II
Ashworth scale 2-3 (For Gastrocnemius Muscle)
Good cognitive ability to understand the orders in the tests
CP children who continued to take regular physiotherapy sessions
Exclusion Criteria:
Recent correcting orthopaedic surgeries until 6 months before recruitment
Children received or intending to receive Botox within an interval of 3 months
Children who have full Ankle dorsal flexion.
fixed contracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra G. Topco, PhD
Organizational Affiliation
Eastern Medeterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Palestine Ahliya university
City
Bethlehem
ZIP/Postal Code
p158
Country
Palestinian Territory, occupied
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Ankle Mobilization on Body Structure, Function, Activities and Participation of Children With Cerebral Palsy
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