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

NCT05042570 | Unknown DMC

• 1 other identifier: EAvcil2
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Instrument Assisted Soft Tissue Mobilization; Stretching Exercises

Outcome Measures

Primary Outcomes (4)

• 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.

  one month

• 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.

  one month

• 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.

  one month

• 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.

  one month

Study Arms (3)

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

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.

Other: Instrument Assisted Soft Tissue Mobilization

Stretching Exercises

EXPERIMENTAL

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.

Other: Stretching Exercises

Control

ACTIVE COMPARATOR

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.

Other: Control Group / NDT program

Interventions

Instrument Assisted Soft Tissue Mobilization 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.

Instrument Assisted Soft Tissue Mobilization

Stretching Exercises 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.

Stretching Exercises

Control Group / NDT program 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.

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises; Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• İpek Yeldan, Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Eren Avcıl, Master

CONTACT

+9005320683378; erenavcil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: September 13, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

TU (1)