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Completed

NCT Number: NCT06608693

Effect of Different Stretching Techniques

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Emniyet Mahallesi Bandırma Caddesi, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNF Stretching

Other

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 group

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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'.

  6. Age in years

    Time frame: 3 months

    Age of patients will be recorded

  7. Weight in kilograms

    Time frame: 3 months

    Weights of patients will be recorded

  8. Height in meters

    Time frame: 3 months

    Heights of patients will be recorded

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effect of Different stretchıng Techniques on Balance and Functionality in Children With Diplegic Cerebral Palsy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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