- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06608693
Effect of Different Stretching Techniques
January 17, 2025 updated by: Uğur Sözlü, Gazi University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Emniyet Mahallesi Bandırma Caddesi
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Ankara, Emniyet Mahallesi Bandırma Caddesi, Turkey, 06560
- Gazi University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF stretching group
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.
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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.
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Experimental: Static stretching group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hip extension Range of motion in degrees
Time Frame: 3 months
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Hip extension ROM was measured with a digital goniometer while the patient was lying in the prone position, and the knee was flexed.
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3 months
|
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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.
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3 months
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Timed Up and Go test (TUG)
Time Frame: 3 months
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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.
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3 months
|
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The Pediatric Berg Balance Scale (PBBS)
Time Frame: 3 months
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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.
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3 months
|
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Gilette Functional Assessment Questionnaire (FAQ)
Time Frame: 3 months
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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'.
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3 months
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Age in years
Time Frame: 3 months
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Age of patients will be recorded
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3 months
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Weight in kilograms
Time Frame: 3 months
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Weights of patients will be recorded
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3 months
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Height in meters
Time Frame: 3 months
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Heights of patients will be recorded
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Selda Başar, Dr, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2024
Primary Completion (Actual)
December 27, 2024
Study Completion (Actual)
December 29, 2024
Study Registration Dates
First Submitted
September 12, 2024
First Submitted That Met QC Criteria
September 19, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 17, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- (KAEK-118/055)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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