NCT06686719

Brief Summary

The purpose of the study is to compare the effect of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy. A randomized control trial was conducted at PAF School for PSN NUR KHAN Rawalpindi. The sample size was 30 calculated through G-Power tool. The participants were divided into three interventional groups each having 10 participants. The study duration was six months. Sampling technique applied was Convenient sampling for recruitment and group randomization using lottery method. Only 8 to 18 years Spastic Dipelgic CP children with Modified Asworth Scale having score 1, 1+ and 2 were included in the study. Tools used in this study are Goniometer, Modified Ashworth Scale, Active knee extension test, Weight bearing lunge test. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 26.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Spastic Cerebral PalsyMyofascialSpasticity

Outcome Measures

Primary Outcomes (2)

  • Modified Ashworth Scale

    Changes from the baseline spasticity measured with help of modified ashworth scale

    Four Weeks

  • Range of motion

    Changes from baseline range of motion of hip, knee and ankle will be measured with help of goniometer.

    Four Weeks

Secondary Outcomes (2)

  • Active Knee Extension Test

    Four Weeks

  • Weight Bearing Lunge Test

    Four Weeks

Study Arms (3)

Post Facilitation group

EXPERIMENTAL

subjects are asked to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand

Other: Post Facilitation

Post Isometric Relaxation

ACTIVE COMPARATOR

Subjects are asked to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax. After relaxation, the therapist further extends the knee for 3 to 5 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand.

Other: Post Isometric Relaxation

Myofascial Release

ACTIVE COMPARATOR

MFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins.

Other: Myofascial Release

Interventions

For hamstring muscle, the patient positioned in supine with hip and knee flexed to mid- range. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand.

Post Facilitation group

For hamstring muscle, the patient positioned in supine with hip and knee flexed. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax.After relaxation, the therapist further extends the knee for 3 to 5 seconds.. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand.

Post Isometric Relaxation

MFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins. Stretching of the hip adductors, hip flexors and plantar flexors. Functional training includes kneeling, bridging and sit to stand.

Myofascial Release

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Spasticity score of less than 3 on MAS
  • Known cases of Spastic diplegic cerebral palsy.
  • Children who follow commands.

You may not qualify if:

  • Epilepsy history
  • hip or spinal deformities
  • Severe contractures, joint dislocations
  • Discrepancy in leg length
  • Recent orthopedic surgery
  • Children with cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAF School For PSN NUR KHAN

Rawalpindi, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegicCerebral PalsyMuscle Spasticity

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ammanullah Nazir, PHD*

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Arslan Malik, MS*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 13, 2024

Study Start

May 3, 2024

Primary Completion

December 3, 2024

Study Completion

December 13, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations