Cerebral PalsyIASTMNCT05042570
The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in Cerebral Palsy
A study testing Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises on Flexibility, Spasticity and Balance in Individuals With Cerebral Palsy
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.
Read the 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
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Stretching Exercises, Control Group / NDT program
- Keywords
- Cerebral Palsy, Instrument Assisted Soft Tissue Mobilization, Stretching Exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
- 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 ExercisesOther
- 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 / NDT programOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control Group / NDT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Avcıl, Istanbul University - Cerrahpasa
- Investigators
- İpek Yeldan, Prof, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042570
- Sponsor's protocol ID
- EAvcil2
- Acronym
- IASTM
- Status last verified
- Sep 2021
- First submitted
- 1 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises on Flexibility, Spasticity and Balance in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05042570
- Acronym / sponsor ID
- IASTM / EAvcil2
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Instrument Assisted Soft Tissue Mobilization, Stretching Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationGroup 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. |
| Stretching Exercises | Experimental | Other: Stretching ExercisesGroup 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. |
| Control | Active comparator | Other: Control Group / NDT programGroup 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Instrument Assisted Soft Tissue Mobilization |
| 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. | Other | Stretching Exercises |
| 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. | Other | Control |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: 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)
Time frame: 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.
Selective Motor Control Test (SMCT)
Time frame: 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.
Weight-Bearing Lunge Testi (WBLT)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İpek Yeldan, Prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eren Avcıl, Master (+9005320683378, erenavcil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.