- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06686719
Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release in Spastic Cerebral Palsy.
Comparison of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a disorder affecting movement, resulting from permanent damage to posture and motor development during fetal or infant brain development, caused by non-progressive disturbances. CP affecting about 1 in 500 children with an estimated prevalence of 17 million people worldwide. In CP, spasticity is often regarded to be the most common motor impairment. Spastic cerebral palsy stands out as the predominant subtype, constituting 77% of all cases, with bilateral spastic cerebral palsy dominating the spastic group (70%). Spasticity is only one of several components of the upper motor neuron (UMN) syndrome. Spasticity is a form of hypertonia due to hyperexcitable tonic stretch reflexes. Adult CP reported that 77% of CP children were having problems with spasticity. Hypertonicity resulting in abnormal movement patterns in both gross motor function and manual abilities in the children with CP.
Traditionally the treatment of tightness in children with spasticity has consisted primarily of techniques which involve static stretching, strengthening of the antagonistic muscles, use of orthosis and postural education etc. Some authorities also recommend Myofascial release to cause elongation of the spastic muscle with a component of tightness. Myofascial therapy can be defined as "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". Akta Bhalara et al (2014) concluded in a study that myofascial release is effective in reducing spasticity in children suffering from spastic diplegic cerebral palsy. A study conducted in 2018 proved that myofascial release is effective in reducing spasticity of hamstring muscle and improves range of motion in spastic diplegic cerebral palsy. Ujwal Bhattacharya et al (2017) in a study concluded that MFR and passive stretching is effective in reducing spasticity and improving range of motion in spastic diplegic Cerebral Palsy.
Fred Mitchell first described MET in 1948 as a type of osteopathic manipulative diagnosis and treatment, primarily utilized to address somatic dysfunction, particularly issues such as reduced range of motion, muscular hypertonicity, and pain. MET involves the use of two physiological phenomena: Post Isometric Relaxation and Reciprocal Inhibition. Post Isometric Relaxation is a technique that was later developed by Karel Lewitt . Post Isometric Relaxation (PIR) is the effect of the decrease in muscle tone in a single or group of muscles, after a brief period of submaximal isometric contraction of the same muscle.
Preeti Gazbare et al ( 2018) conducted a Comparative Study On The Effect of Myofascial Release Over Post Isometric Relaxation On Calf Muscle Tone in Spastic Diplegic Cerebral Palsy and concluded that both MFR and PIR are equally effected in reducing calf muscle tone in spastic Cerebral Palsy. PIR improves better flexibility and decrease tightness of hamstring muscle as compared to static stretching. MET improves the independent mobility of stroke patients with hemiplegia enhances balance and stability. Janstephan T (2015) conducted a study to evaluate the effectiveness of neurodevelopment therapy with post isometric relaxation for lower extremity to improve functional ability in children with spastic diplegic cerebral palsy. The result suggested that neurodevelopmental therapy along with muscle energy technique improved the functional ability in children with spastic diplegic cerebral palsy.
Post Facilitation Stretch (PFS) is a technique developed by Janda.This technique is more aggressive than PIR but is also based on the concept of autogenic inhibition. Post facilitation stretching is a MET technique which uses postisometric relaxation. The term refers to the effect of the subsequent relaxation experienced by a muscle after an isometric contraction has been performed. The effect of a sustained contraction on the Golgi tendon organs seems pivotal, since their response to such a contraction seems to be set the tendon and the muscle to a new length by inhibiting it. A study concluded that Post Facilitation Stretching is effective in increasing Flexibility of tight hamstring muscles. A study concluded that post facilitation stretch is effective in reducing pain and improving muscle length. A study in published in 2024 compared the effect of the muscle energy technique (MET) and stretching technique on ankle dorsiflexion passive range of motion, balance, and gait ability of stroke patients with limited ankle dorsiflexion. And concluded that MET and Stretching both are effective in improving range of motion , balance and gait ability of stroke patients with limited ankle dorsiflexion.
The rationale for this study is that Post-facilitation stretch relaxation (PFSR) is proposed as an effective intervention for reducing lower limb spasticity in spastic cerebral palsy. By combining passive stretching with relaxation techniques post- facilitation, PFSR aims to decrease muscle tone and improve range of motion. This approach is individualized, often integrated with other therapies, and emphasizes patient education for long term management.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: +923324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Arslan Malik, MS*
- Phone Number: +923335757407
- Email: arslan967m@gmail.com
Study Locations
-
-
-
Rawalpindi, Pakistan
- Recruiting
- PAF School For PSN NUR KHAN
-
Contact:
- Muhammad Arslan Malik, MS*
- Phone Number: +923335757407
- Email: arslan967m@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Spasticity score of less than 3 on MAS
- Known cases of Spastic diplegic cerebral palsy.
- Children who follow commands.
Exclusion Criteria:
- Epilepsy history
- hip or spinal deformities
- Severe contractures, joint dislocations
- Discrepancy in leg length
- Recent orthopedic surgery
- Children with cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post Facilitation group
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 |
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. |
|
Active Comparator: Post Isometric Relaxation
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. |
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. |
|
Active Comparator: Myofascial Release
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale
Time Frame: Four Weeks
|
Changes from the baseline spasticity measured with help of modified ashworth scale
|
Four Weeks
|
|
Range of motion
Time Frame: Four Weeks
|
Changes from baseline range of motion of hip, knee and ankle will be measured with help of goniometer.
|
Four Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Knee Extension Test
Time Frame: Four Weeks
|
Changes from the baseline hamstring tightness will be measured with active knee extension test
|
Four Weeks
|
|
Weight Bearing Lunge Test
Time Frame: Four Weeks
|
Changes from the baseline calf tightness will be measured with weight bearing lunge test
|
Four Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ammanullah Nazir, PHD*, Riphah International University Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/RCRAHS/REC/MS-PT/01942
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spastic Diplegia Cerebral Palsy
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
Cairo UniversityRecruitingCerebral Palsy (CP) | Spastic DiplegiaEgypt
-
Wroclaw University of Health and Sport SciencesNot yet recruitingSpastic Diplegia Cerebral Palsy | Spastic HemiplegiaPoland
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Cairo UniversityUnknownSpastic Diplegia Cerebral PalsyEgypt
-
TC Erciyes UniversityEnrolling by invitationCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyTurkey
-
Cairo UniversityNot yet recruiting
-
Universitat de LleidaNot yet recruitingCerebral Palsy, SpasticSpain
Clinical Trials on Post Facilitation
-
Riphah International UniversityRecruitingAutism Spectrum DisorderPakistan
-
University of LahoreRecruitingErector Spinae TightnessPakistan
-
Riphah International UniversityCompletedDisability | Range of Motion | Flexibility | HamstringsPakistan
-
Sehat Medical ComplexCompletedHamstring InjuryPakistan
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedPost Traumatic Stiff ElbowPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityRecruiting