The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in Cerebral Palsy

Not Applicable

• Conditions: Cerebral Palsy

• Registration Number: NCT05042570
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

The aim of the study; To investigate the effects of Instrument Assisted Soft Tissue Mobilizations and Stretching Exercises on flexibility, spasticity, balance and functional mobility in patients with CP.

Detailed Description

Various intervention studies; reported positive results with EDYDM after carpal tunnel syndrome, myofascial trigger point, chronic low back pain, nonspecific thoracic spine pain, ankle instability, mastectomy and total joint arthroplasty. Observational studies have shown positive results in improving posterior shoulder range of motion, hip, knee, and ankle ROM.

There is no study in the literature with EDYDM in patients with CP. Many of the problems in which EDDM is applied for fascia and muscle mobilization in different diseases are also seen in patients with CP. In current rehabilitation methods, Stretching Exercises are applied for muscle and fascia shortening. The advantages of the applications over each other are unknown. Our study is planned as a study with high original value as it is the first study to be conducted using EDYDM in cases with CP. In our study, the effectiveness of EDYDM treatment, which will increase the effectiveness of stretching exercises in CP or can be an alternative treatment approach in cases with CP, will be compared with Stretching Exercises.

Study Timeline

• Study First Submitted: 2021-08-01
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-13
• Last Update Posted: 2021-09-13
• Study Start: 2021-11-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Having been diagnosed with Unilateral Spastic Type Cerebral Palsy by the health committee report,
• Level I or II according to GMFCS,
• Being between the ages of 5-18,
• No Botulinum Toxin (Botox) injection in the last 6 months,
• Not using any medication that may affect muscle tone,
• Passive ankle dorsiflexion + 10o and passive plantar flexion -25o,
• Families and children agree to participate voluntarily in the study.

Exclusion Criteria

• Having undergone any lower extremity surgery,
• Tone in plantar flexors is level IV according to MAS,
• Presence of advanced contracture in the ankle,
• Presence of any diagnosed cardiac or orthopedic disorder that may prevent the application of the treatment,
• Hearing or vision problems,
• Having a history of epileptic attacks,
• Not having the ability to adapt to exercises (cases with the phrase "Mental Retarde" according to the health report).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Selective Motor Control Test (SMCT)	one month	Ankle dorsiflexion Selective Motor Control Test will be used in the evaluation of selective movements. This test evaluates the isolated dorsiflexion movement of the ankle and is evaluated between 0-4 according to the selectivity of the ankle dorsiflexion movement in the long sitting position.
Modified Ashworth Scale (MAS)	one month	In the evaluation of the presence of spasticity in patients with CP, the ankle plantar flexors will be based. It is recorded as an assessment of the resistance encountered while passively moving the limb at full range of motion. It is scored as 0, 1, 1+, 2, 3, 4. A value of 0 is the best score without muscle tone increase, while a value of 4 is when the extremity is in a rigid position. Modified Ashworth Scale (MAS) will be used to evaluate spasticity.
Pediatric Berg Balance Scale (PBBS)	one month	The Pediatric Berg Balance Scale, which is the version of the Berg Balance Scale designed for children by Franjoine et al., will be used to evaluate their functional balance in activities of daily living. The scale consists of 14 sections and each section is scored between 0-4; The highest score that can be obtained from the scale is 56.
Weight-Bearing Lunge Testi (WBLT)	one month	In order to measure the weight-bearing dorsiflexion ROM, the Weight-Bearing Lunge Test, which is positioned with support from the wall in the closed chain position, will be applied. An increase in ankle dorsiflexion angle will be considered as a positive result.

Trial Locations

Locations (1)

Istanbul University Cerrahpasa; 🇹🇷 Istanbul, Turkey