NCT06646718

Brief Summary

Purpose of the study: To evaluate the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

January 30, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 14, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Isokinetic dynamometry:

    Isokinetic dynamometry testing is a device used within sports and exercise science as well as clinical testing environments that is used to evaluate joint torque. Isokinetic dynamometers are able to test the strength (torque) and power of different muscle groups. is a safe and reliable method accepted as the "gold standard" in the evaluation of muscle strength. It will be used before and after intervention to measure muscle strength

    12 weeks

  • X-ray:

    used to assess the alignment of the hip joint, detect any abnormalities, and determine the degree of bone deformities or hip dislocation. Will be used before and after intervention to determine hip angles

    12 weeks

  • The Pediatric Balance Scale:

    The Pediatric Balance Scale (PBS), which is a modification of Berg Balance Scale (BBS) designed for children and adolescents aged 5 to 15 years, to assess functional balance abilities. The scale is composed of 14 items that are scored on a criterion-based 0 to 4 scale. The range of scores in the PBS is 0 to 56. each activity is rated on a five-point scale (0-4) so that the maximum score is 56. Patients who score 41 or higher are considered to be a low fall risk, those who score between 21 and 40 are considered to be moderate fall risks, and those who score below 20 are considered to be high fall risks. It will be completed in 15-20 minutes

    12 weeks

Study Arms (2)

❖ Experimental Group: group A

EXPERIMENTAL

Group A (study group): will include 33 children after selective dorsal rhizotomy surgery from both gender will be selected from the Outpatient Clinic. Able to attend physical therapy (PT) treatment at least three a week before and during this study. who will receive closed kinetic chain.

Procedure: Close kinetic chain exercise group

❖ Control Group:Group B

OTHER

●Group B (control group): will include 33 children who will receive Traditional physiotherapy. will include 33 children after selective dorsal rhizotomy surgery from both gender

Procedure: Traditional physical therapy.

Interventions

●Close kinetic chain exercise group: group A will receive forward step-ups, lateral step-ups, squats, sit-to-stand, and stoop-and-recover exercises. session will be initiated with a 10 min warm-up period, including stretching of the major muscles and muscle groups, then 40 min different exercises and terminated with a 10 min cool-down period in the form of aerobic exercises.

Also known as: Experimental group intervention
❖ Experimental Group: group A

●Traditional physiotherapy: group B will receive stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles; and strengthening exercises for core muscles, hip extensors, flexors and abductors, internal and external rotators of the hip, flexors and extensors of the knee, ankle dorsi flexors, kneeling exercises, and standing and gait training

Also known as: Control group intervention
❖ Control Group:Group B

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients will be aged from 5 to 14 years
  • will be included both genders post selective dorsal rhizotomy.
  • The GMFCS level I-II spastic diplegia, able to stand up from a chair independently and maintain standing for more than 5 seconds without falling.
  • Had not received any strength training program in the past 3 months before the study.
  • Able to attend physical therapy (PT) treatment at least three a week before and during this study.

You may not qualify if:

  • have perceptual, cognitive, visual and auditory disorder.
  • botulinum toxin injection to the lower extremities within 6 Months.
  • Medical conditions that prevented children from participating in the exercises.
  • Previous lower extremity surgery, such as prior hamstring muscle Lengthening. 5- Existence of any orthopedic condition or any static hip, knee or ankle deformities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Kafr elsheikh University

Kafr ash Shaykh, Kafr Elsheikh, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Abdelaziz Ali Sherief, Professor

    Kafr elsheikh University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * The study will include children (age 5-14years) post selective dorsal rhizotomy. * Children meeting the inclusion criteria will be randomly assigned to one of two groups: * Experimental Group: children in this group will receive closed kinetic chain. * Control Group: Patients in this group will receive Traditional physical therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 17, 2024

Study Start

January 30, 2024

Primary Completion

October 12, 2024

Study Completion

October 20, 2024

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations