Cerebral PalsyNCT06608693
Effect of Different Stretching Techniques
A study testing PNF stretching and Static stretching group in people with Cerebral Palsy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- PNF stretching and Static stretching group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to 29 Dec 2024
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A clinical diagnosis of CP;
- Age ranging from 6 to 18 years;
- No recent administration of Botulinum Toxin to the lower extremity muscles in the last 6 months;
- An IQ score of 70 or above;
- A Gross Motor Function Classification System (GMFCS) value of 1, 2 or 3;
- Presence of hip flexion contracture;
- Willingness to participate in the study
Who cannot join
- Concomitant diagnoses aside from CP,
- Presenting with muscle tone ratings of 3 or 4 in the hip muscles according to the Modified Ashworth Scale (MAS),
- Who had undergone tendon lengthening surgery to increase hip flexion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University
Ankara, Emniyet Mahallesi Bandırma Caddesi, 06560
About this study
Official title: Effect of Different stretchıng Techniques on Balance and Functionality in Children With Diplegic Cerebral Palsy
The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP).
Read the detailed description
The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP). The study consisted of a group of sixteen children, ranging in age from 8 to 16 years, who were diagnosed with bilateral hip flexor contracture and diplegic cerebral palsy. These children were classified according to the Gross Motor Function Classification System (GMFCS) levels I to III. The children were randomly divided into PNF and static stretching groups. Stretching techniques were applied 2 days a week for 4 weeks, with 6 repetitions in each session. The study assessed various parameters, including hip extension range of motion (ROM), muscle tone intensity based on the Modified Ashworth Scale, hip flexor shortness as determined by the Thomas Test, the time up and go (TUG) test, balance using the Pediatric Berg Balance Scale, and functional status evaluated through the Gilette Functional Walking Assessment Questionnaire.
- Conditions
- Cerebral Palsy
- Being tested
- PNF stretching, Static stretching group
- Keywords
- PNF, Static Stretching, Balance, Functionality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF stretchingOther
Subjects lay supine on a treatment table, holding one knee to the chest and letting the other leg extend freely toward the floor at the end of the table. This protocol was adapted from previous studies. The hip joint was carefully and gradually lowered towards the floor, with the knee flexing at a 90-degree angle until the individual experienced a mild stretching sensation (Visual analog scale:4-6). Then, the subject performed a sub-maximal voluntary isometric contraction by utilizing the flexor muscles for 20 seconds while resisting the applied force exerted by an examiner through the utilization of a hand-held dynamometer (K-Force Muscle Control). The examiner proceeded to passively manipulate the leg to achieve the desired range of motion (ROM), maintaining it for 20 seconds. This process was repeated six times for each limb. The patient rested for 2 minutes before applying the same technique to the other side.
Static stretching groupOther
While the patient was lying supine, the hip and knee joints on the non-stretch side were kept in 90⸰ flexion. A sandbag was positioned on the side to be stretched, specifically proximal to the patella, in order to induce a moderate sensation of stretching in the patient. Subsequently, a force was exerted in the direction of hip extension for a duration of 30 seconds. Afterward, the patient was instructed to relax. This process was repeated a total of six times, with a designated 20-second rest period between each repetition. The patient took a two-minute rest before the same technique was applied to the other side. There was no specific order on which side to apply the technique.
| Study group | Role | What they receive |
|---|---|---|
| PNF stretching group | Experimental | PNF and static stretching methods were applied 2 days a week and 6 repetitions in each session for 4 weeks to the hip flexors. In addition to stretching, both of the groups received a routine treatment program consisting of gluteus maximus and quadriceps strengthening, balance, and walking exercises. Receives: Other: PNF stretching |
| Static stretching group | Experimental | PNF and static stretching methods were applied 2 days a week and 6 repetitions in each session for 4 weeks to the hip flexors. In addition to stretching, both of the groups received a routine treatment program consisting of gluteus maximus and quadriceps strengthening, balance, and walking exercises. Receives: Other: Static stretching group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip extension Range of motion in degrees
Hip extension ROM was measured with a digital goniometer while the patient was lying in the prone position, and the knee was flexed.
Measured: 3 months
Thomas test
The degree of hip flexion contracture was determined using the Thomas test while the patient was supine. The opposite hip was passively moved in the flexion direction as much as possible by a second physiotherapist. In the meantime, the degree of hip flexion on the designated side was assessed using a digital goniometer and documented in degrees. This test was repeated 3 times, and the results were averaged.
Measured: 3 months
Timed Up and Go test (TUG)
Functional status was assessed by the Timed Up and Go test (TUG). The time required for the patient to get up from the chair, walk 3 meters, turn around, walk back to the chair, and sit down was calculated in seconds. The test was repeated 3 times, and the data average was recorded.
Measured: 3 months
The Pediatric Berg Balance Scale (PBBS)
The Pediatric Berg Balance Scale (PBBS) was used to evaluate dynamic balance skills in children with CP. The scale comprises 14 items including sitting balance,standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, reaching the foor, turning, and placing foot on stool items. Each item ranked from 0 to 4. 0 shows inability to perform the instruction, while 4 shows the ability to perform without any difculty. Maximum total score is 56.
Measured: 3 months
Gilette Functional Assessment Questionnaire (FAQ)
Gillette Functional AssessmentQuestionnaire (FAQ) 22-item asks the respondent to 'Please ratehow easy it is for the patient to do the following activities'followed by brief descriptions of 22 locomotor skills the five-level (minumum:1, maximum:5) Likert response scale used for the 22 skill items was 'easy', 'a little hard', 'very hard', 'can't do at all',and 'too young for activity'.
Measured: 3 months
Age in years
Age of patients will be recorded
Measured: 3 months
Weight in kilograms
Weights of patients will be recorded
Measured: 3 months
Height in meters
Heights of patients will be recorded
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start27 Sep 2024
- Primary completion27 Dec 2024
- Study completion29 Dec 2024
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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur Sözlü, Gazi University
- Investigators
- Selda Başar, Dr, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608693
- Sponsor's protocol ID
- (KAEK-118/055)
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different stretchıng Techniques on Balance and Functionality in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06608693
- Acronym / sponsor ID
- (KAEK-118/055)
- Conditions
- Cerebral Palsy
- Keywords
- PNF, Static Stretching, Balance, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 23 Sep 2024 (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 this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP).
Detailed description
The aim of this study is to investigate the effect of proprioceptive neuromuscular facilitation (PNF) and static stretching techniques on the balance and functional capabilities of children diagnosed with diplegic cerebral palsy (CP). The study consisted of a group of sixteen children, ranging in age from 8 to 16 years, who were diagnosed with bilateral hip flexor contracture and diplegic cerebral palsy. These children were classified according to the Gross Motor Function Classification System (GMFCS) levels I to III. The children were randomly divided into PNF and static stretching groups. Stretching techniques were applied 2 days a week for 4 weeks, with 6 repetitions in each session. The study assessed various parameters, including hip extension range of motion (ROM), muscle tone intensity based on the Modified Ashworth Scale, hip flexor shortness as determined by the Thomas Test, the time up and go (TUG) test, balance using the Pediatric Berg Balance Scale, and functional status evaluated through the Gilette Functional Walking Assessment Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF stretching group | Experimental | Other: PNF stretchingPNF and static stretching methods were applied 2 days a week and 6 repetitions in each session for 4 weeks to the hip flexors. In addition to stretching, both of the groups received a routine treatment program consisting of gluteus maximus and quadriceps strengthening, balance, and walking exercises. |
| Static stretching group | Experimental | Other: Static stretching groupPNF and static stretching methods were applied 2 days a week and 6 repetitions in each session for 4 weeks to the hip flexors. In addition to stretching, both of the groups received a routine treatment program consisting of gluteus maximus and quadriceps strengthening, balance, and walking exercises. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- A clinical diagnosis of CP;
- Age ranging from 6 to 18 years;
- No recent administration of Botulinum Toxin to the lower extremity muscles in the last 6 months;
- An IQ score of 70 or above;
- A Gross Motor Function Classification System (GMFCS) value of 1, 2 or 3;
Key exclusion criteria (3 listed)
- Concomitant diagnoses aside from CP,
- Presenting with muscle tone ratings of 3 or 4 in the hip muscles according to the Modified Ashworth Scale (MAS),
- Who had undergone tendon lengthening surgery to increase hip flexion
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 |
|---|---|---|
| PNF stretchingSubjects lay supine on a treatment table, holding one knee to the chest and letting the other leg extend freely toward the floor at the end of the table. This protocol was adapted from previous studies. The hip joint was carefully and gradually lowered towards the floor, with the knee flexing at a 90-degree angle until the individual experienced a mild stretching sensation (Visual analog scale:4-6). Then, the subject performed a sub-maximal voluntary isometric contraction by utilizing the flexor muscles for 20 seconds while resisting the applied force exerted by an examiner through the utilization of a hand-held dynamometer (K-Force Muscle Control). The examiner proceeded to passively manipulate the leg to achieve the desired range of motion (ROM), maintaining it for 20 seconds. This process was repeated six times for each limb. The patient rested for 2 minutes before applying the same technique to the other side. | Other | PNF stretching group |
| Static stretching groupWhile the patient was lying supine, the hip and knee joints on the non-stretch side were kept in 90⸰ flexion. A sandbag was positioned on the side to be stretched, specifically proximal to the patella, in order to induce a moderate sensation of stretching in the patient. Subsequently, a force was exerted in the direction of hip extension for a duration of 30 seconds. Afterward, the patient was instructed to relax. This process was repeated a total of six times, with a designated 20-second rest period between each repetition. The patient took a two-minute rest before the same technique was applied to the other side. There was no specific order on which side to apply the technique. | Other | Static stretching group |
Primary outcome
Hip extension Range of motion in degrees
Time frame: 3 months
Hip extension ROM was measured with a digital goniometer while the patient was lying in the prone position, and the knee was flexed.
Thomas test
Time frame: 3 months
The degree of hip flexion contracture was determined using the Thomas test while the patient was supine. The opposite hip was passively moved in the flexion direction as much as possible by a second physiotherapist. In the meantime, the degree of hip flexion on the designated side was assessed using a digital goniometer and documented in degrees. This test was repeated 3 times, and the results were averaged.
Timed Up and Go test (TUG)
Time frame: 3 months
Functional status was assessed by the Timed Up and Go test (TUG). The time required for the patient to get up from the chair, walk 3 meters, turn around, walk back to the chair, and sit down was calculated in seconds. The test was repeated 3 times, and the data average was recorded.
The Pediatric Berg Balance Scale (PBBS)
Time frame: 3 months
The Pediatric Berg Balance Scale (PBBS) was used to evaluate dynamic balance skills in children with CP. The scale comprises 14 items including sitting balance,standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, reaching the foor, turning, and placing foot on stool items. Each item ranked from 0 to 4. 0 shows inability to perform the instruction, while 4 shows the ability to perform without any difculty. Maximum total score is 56.
Gilette Functional Assessment Questionnaire (FAQ)
Time frame: 3 months
Gillette Functional AssessmentQuestionnaire (FAQ) 22-item asks the respondent to 'Please ratehow easy it is for the patient to do the following activities'followed by brief descriptions of 22 locomotor skills the five-level (minumum:1, maximum:5) Likert response scale used for the 22 skill items was 'easy', 'a little hard', 'very hard', 'can't do at all',and 'too young for activity'.
Age in years
Time frame: 3 months
Age of patients will be recorded
Weight in kilograms
Time frame: 3 months
Weights of patients will be recorded
Height in meters
Time frame: 3 months
Heights of patients will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
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.
Selda Başar, Dr study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF stretching and Static stretching group in people with Cerebral Palsy, run by Gazi University 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 3 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: finished, as of the sponsor's last update on 20 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip extension Range of motion in degrees (time frame: 3 months). The study lists 8 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 20 Jan 2025.