Effects of Ankle Mobilization on Body Structure, Function, Activities and Participation of Children With Cerebral Palsy

The Effects of Ankle Mulligan Mobilization on Range of Motion, Balance, Functional Performance and Quality of Life of Children With Diplegic Spastic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Diplegic Cerebral Palsy With Spasticity
• Intervention / Treatment: Other: Intervention group

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?

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Bethlehem, Palestinian Territory, occupied, p158
    • Palestine Ahliya university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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	Other: Intervention group; 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
Experimental: Control group; 5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging	Other: Intervention group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ankle Range of Motion	ROM of Ankle Dorsiflexion passively and actively will be done using goniometer to assess any changes.	Baseline and post 4 weeks assessment
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	Baseline and post 4 weeks assessment
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	Baseline and post 4 weeks assessment
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	Baseline and post 4 weeks assessment
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	Baseline and post 4 weeks assessment

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Zehra G. Topco, PhD, Eastern Medeterranean University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: ETK00-2022-0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No