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

NCT ID: NCT05042570

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-12-01

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Instrument Assisted Soft Tissue Mobilization

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 Type: EXPERIMENTAL

Instrument Assisted Soft Tissue Mobilization

Intervention Type: OTHER

• 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.

Stretching Exercises

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 Type: EXPERIMENTAL

Stretching Exercises

Intervention Type: OTHER

• 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Control Group / NDT program

Intervention Type: OTHER

• 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.

Interventions

Instrument Assisted Soft Tissue Mobilization

• 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

Stretching Exercises

• 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

Control Group / NDT program

• 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Eren Avcıl

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İpek Yeldan, Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Eren Avcıl, Master

Role: CONTACT

erenavcil@gmail.com

+9005320683378

Other Identifiers

EAvcil2

Identifier Type: -

Identifier Source: org_study_id