Clinical trial NCT06198101: Effects of Myofascial Release Technique on Upper Limb Functions in Cerebral Palsy
Official title: Effects of Myofascial Release Technique With and Without Segmental Vibrator on Upper Limb Functions in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: CP child
Myofascial release technique
Segmental vibrator
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive Myofascial release technique and group B will receive Myofascial release technique with segmental massage vibrator
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a common neurodevelopmental disorder characterized by motor impairments, including spasticity, muscle tightness, and limited range of motion in the limbs. Myofascial Release Technique (MRT) has shown promise as a non-invasive intervention for addressing musculoskeletal dysfunctions and improving range of motion in various populations.

The study will employ a randomized controlled trial design to investigate the effects of myofascial release technique (MRT) with and without a segmental vibrator on upper limb functions in children with spastic cerebral palsy (CP). The study will be conducted at PSRD and Rising Sun Institute Lahore. A sample of children aged 6-12 years with a diagnosis of spastic CP will be recruited and randomly assigned to two groups: MRT with a segmental vibrator, and MRT without a segmental vibrator. The MRT interventions will be provided by trained therapists for a specified duration and frequency over a period of 4 weeks. Spasticity will be measured by the Modified Ashwarth Scale, Upper limb extremity function via Pediatric Upper Extremity Motor Activity Log-Revised (PMAL), and range of motion will be assessed by Goniometer. Data will be analyzed using appropriate statistical tests to determine the effects of the interventions on upper limb functions in children with spastic CP. Ethical considerations will be followed, and informed consent will be obtained from the participant's parents or legal guardians.

Detailed description: Group A will receive only myofascial release technique through longitudinal sliding and cross handed held method to the upper limb flexors, extensors, and wrist flexors. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied with different levels according to subject's tolerance for duration of 3 minutes in each sitting. Level one will be performed by longitudinal movements without causing any tension to the tissues. The level two will be performed by longitudinal movements with light pressure to the tensed muscle. The level three will be performed by compressing the treatment area then passively fullest possible range of motion will be performed and then longitudinal movement will be done with same compression. In level four, the patient will actively move the tissue through the fullest possible range of motion. The taut band will palpate and then firm pressure will be maintained and then longitudinal movements will be performed. Treatment will be applied for two intervention sessions per week and a total of 12 sessions over 6 weeks.

Group B will receive vibratory stimulations through segmental vibrator along the muscle fibers of upper limb flexors, extensors, and wrist flexors for 10-minutes each session with low amplitude (0.3-0.5 mm peak to peak) at fixed frequency of 150 Hz. Along with segmental vibrator group B will also receive myofascial release technique through the same method to the upper limb flexors, extensors, and wrist flexors. Group B will receive both treatments for two intervention sessions per week and a total of 12 sessions over 6 weeks.

Eligibility criteria: Inclusion Criteria

* Children aged 6-12 years.
* Both Boys and Girls
* Spasticity above 1+ grade of ashworth scale
* Ability to follow instructions and participate in therapy sessions

Exclusion Criteria:

* Unable to follow command.
* Multiple Musculoskeletal deformities or contractures that may limit upper limb function.
* Children who are Contraindicated to myofascial release technique or the use of a segmental vibrator for example burn.
* Recent upper limb surgery or significant upper limb injuries.
* Participation in any other concurrent therapy or intervention for upper limb function.
* Inability to commit to the study protocol or attend scheduled therapy sessions

Primary outcomes:
measure: Modified Ashwarth Scale
timeFrame: 6 weeks
measure: The Pediatric Upper Extremity Motor Activity Log-Revised (PMAL)
timeFrame: 6 weeks
measure: Goniometer
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maryam Mangrio, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.