search
Back to results

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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
Stretching Exercises
Control Group / NDT program
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Instrument Assisted Soft Tissue Mobilization, Stretching Exercises

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Istanbul University Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Instrument Assisted Soft Tissue Mobilization

Stretching Exercises

Control

Arm Description

Group 1 (n=13): Each session will consist of 40 minutes. An additional 10 minutes of IASTM will be performed to the 30-minute NDT program.

Group 2 (n=13): Each session will consist of 40 minutes. In addition to the NDT program applied for 30 minutes, 10 minutes of Stretching Exercises will be performed.

Group 3 (n=13): Each session will consist of 40 minutes. There will be no additional application to the NDT program, which is applied for 40 minutes, and it will be included as a control group in the study.

Outcomes

Primary Outcome Measures

Modified Ashworth Scale (MAS)
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)
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.
Selective Motor Control Test (SMCT)
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.
Weight-Bearing Lunge Testi (WBLT)
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.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2021
Last Updated
September 6, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT05042570
Brief Title
The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in Cerebral Palsy
Acronym
IASTM
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Instrument Assisted Soft Tissue Mobilization, Stretching Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Instrument Assisted Soft Tissue Mobilization
Arm Type
Experimental
Arm Description
Group 1 (n=13): Each session will consist of 40 minutes. An additional 10 minutes of IASTM will be performed to the 30-minute NDT program.
Arm Title
Stretching Exercises
Arm Type
Experimental
Arm Description
Group 2 (n=13): Each session will consist of 40 minutes. In addition to the NDT program applied for 30 minutes, 10 minutes of Stretching Exercises will be performed.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Group 3 (n=13): Each session will consist of 40 minutes. There will be no additional application to the NDT program, which is applied for 40 minutes, and it will be included as a control group in the study.
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Intervention Description
This technique will be performed using instruments of different sizes, shapes and treatment styles. During the application, instruments will be applied to loosen the muscle tissue and fascia by gliding on the tissue at certain angles. The muscle groups to be treated with IASTM are gastrocnemius, soleus and tibialis posterior. It will also be applied to the superficial and deep fascia. The instrument will be sterilized before treatment. IASTM treatment will be applied without damaging the tissue after massaging cream is applied to the muscle fibers with the instrument.
Intervention Type
Other
Intervention Name(s)
Stretching Exercises
Intervention Description
The muscle groups to be applied stretching exercises are gastrocinemius, soleus and tibialis posterior. It will also be applied to the superficial and deep fascia. 3 different functional stretching exercises will be applied; With the hands supported on the wall and with the help of the physiotherapist, the affected extremity is behind the knee in full extension m. gastrocnemius stretching exercise, With the hands supported on the wall and with the help of the physiotherapist, the knee is partially flexed, with the affected extremity behind. soleus stretching exercise, It is a stretching exercise that will be applied by asking the patient to squat without lifting his heels, with the patient's hands supported by the physiotherapist.
Intervention Type
Other
Intervention Name(s)
Control Group / NDT program
Intervention Description
Efforts to eliminate tone disorders, Sensory-perception-motor integrity development studies, Activities aimed at facilitating movements in daily life, Stretching and strengthening exercises due to muscle shortness and weakness, Studies to increase lower and upper extremity functionality, It will include the training of activities such as standing up, walking and balance.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
one month
Title
Pediatric Berg Balance Scale (PBBS)
Description
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.
Time Frame
one month
Title
Selective Motor Control Test (SMCT)
Description
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.
Time Frame
one month
Title
Weight-Bearing Lunge Testi (WBLT)
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eren Avcıl, Master
Phone
+9005320683378
Email
erenavcil@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İpek Yeldan, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs