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

NCT05500924 | Completed

• 1 other identifier: ETK00-2022-0160
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diplegic Cerebral Palsy With Spasticity

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

Intervention group OTHER

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

Control group; Intervention group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Palestine Ahliya university

Bethlehem, p158, Palestinian Territories

Location

Related Publications (1)

• Ragheb Abushameh RS, Topcu ZG, Tunal AN, Amro A, Arab AA. The effects of ankle mulligan mobilisation in children with cerebral palsy: A randomized single blind control study. J Pak Med Assoc. 2024 Jul;74(7):1219-1223. doi: 10.47391/JPMA.10328.

  PMID: 39028043 DERIVED

Study Officials

• Zehra G. Topco, PhD

  Eastern Medeterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 15, 2022
• Study Start: July 30, 2022
• Primary Completion: December 22, 2022
• Study Completion: January 10, 2023
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)