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

NCT ID: NCT05500924

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-30
• Study Completion Date: 2023-01-10

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?

Conditions

Diplegic Cerebral Palsy With Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: 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

5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zehra G. Topco, PhD

Role: STUDY_DIRECTOR

Eastern Medeterranean University

Locations

Palestine Ahliya university

Bethlehem, , Palestinian Territories

Countries

Palestinian Territories

References

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.

Reference Type: DERIVED

PMID: 39028043 (View on PubMed)

Other Identifiers

ETK00-2022-0160

Identifier Type: -

Identifier Source: org_study_id