NCT06608693

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

September 12, 2024

Last Update Submit

January 17, 2025

Conditions

Keywords

PNFStatic StretchingBalanceFunctionality

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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'.

    3 months

  • Age in years

    Age of patients will be recorded

    3 months

  • Weight in kilograms

    Weights of patients will be recorded

    3 months

  • Height in meters

    Heights of patients will be recorded

    3 months

Study Arms (2)

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.

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.

Other: Static stretching group

Interventions

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.

PNF 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.

Static stretching group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

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

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Selda Başar, Dr

    Gazi University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 23, 2024

Study Start

September 27, 2024

Primary Completion

December 27, 2024

Study Completion

December 29, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations