Clinical trial NCT05042570: The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in Cerebral Palsy
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises on Flexibility, Spasticity and Balance in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Instrument Assisted Soft Tissue Mobilization
Stretching Exercises
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 39
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: one month
measure: Pediatric Berg Balance Scale (PBBS)
timeFrame: one month
measure: Selective Motor Control Test (SMCT)
timeFrame: one month
measure: Weight-Bearing Lunge Testi (WBLT)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: İpek Yeldan, Prof
role: STUDY_DIRECTOR
References: