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CompletedNCT06608693Updated Jan 20, 2025

Effect of Different Stretching Techniques

An interventional study of PNF stretching and Static stretching group in Cerebral Palsy, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Gazi University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • PNF
  • Static Stretching
  • Balance
  • Functionality
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's enrollment of 34 is close to the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • 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.

    Other: PNF stretching

  • 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.

    Other: Static stretching group

Interventions

  • OtherPNF stretching

    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.

  • OtherStatic stretching group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

  5. 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'.

    Time frame: 3 months

  6. Age in years

    Age of patients will be recorded

    Time frame: 3 months

  7. Weight in kilograms

    Weights of patients will be recorded

    Time frame: 3 months

  8. Height in meters

    Heights of patients will be recorded

    Time frame: 3 months

07

Study locations

1 site
  • Gazi University
    Ankara, Emniyet Mahallesi Bandırma Caddesi 06560, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Dec 2024, 3 months.

Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 3 months is below that.

Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2024
First posted
Sep 23, 2024
StartActual
Sep 27, 2024
Primary completionActual
Dec 27, 2024
CompletionActual
Dec 29, 2024
Last update
Jan 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06608693
Lead sponsor
Gazi University
Responsible party
Uğur Sözlü (Director, Gazi University) — Principal investigator
First posted
Sep 23, 2024
Start date
Sep 27, 2024
Primary completion
Dec 27, 2024
Completion
Dec 29, 2024
Last update
Jan 20, 2025

Study contacts

Selda Başar, Dr
study chair · Gazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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