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NCT Number: NCT06704880

CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY

This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP.

Participants will:

diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks.

3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.

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Key information

Conditions

Hemiplegic Cerebral Palsy

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Method:

32 children with hemiplegic CP will be equally and randomly allocated to two groups (group A and B). group A will receive lower limb CIMT for the non- hemiplegic limb using whole leg orthosis and Group B will receive strengthen training for the non-hemiplegic lower limb. Both groups will receive routine physical therapy for the hemiplegic lower limb. Both groups will receive 60 minutes training session for 3 sessions per week for 8 consecutive weeks. Assessment will be at baseline then at the end of trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with hemiplegic cerebral palsy aged age between 4 and 10.
  • (GMFCS) levels I, II and III.
  • Able to follow therapist instructions during training session.

Exclusion criteria

  • Lack of patient's cooperation.
  • Difficulty wearing constraint method due to severe joint deformation or/and contracture.
  • Patients were treated with botulinum toxin during the last 3 months.
  • Seizure disorder not fully controlled by medication.

Treatment and study plan

rehabilitation

Other

children in the CIMT group will RECIEVE lower limb CIMT for the non-hemiplegic limb using whole leg orthosis. Children in cross-education group will receive strengthening training for the non-hemiplegic lower limb

Primary outcomes

  1. gait speed

    Time frame: at base line then at the end of the 8 weeks

    gait spatiotemporal parameter

  2. cadence gait spatiotemporal parameter

    Time frame: at base line then at the end of the 8 weeks

    gait spatiotemporal parameter

  3. step length

    Time frame: at base line then at the end of the 8 weeks

    gait spatiotemporal parameter

  4. stride length

    Time frame: at base line then at the end of the 8 weeks

    gait spatiotemporal parameter

Secondary outcomes

  1. Pediatric balance scale

    Time frame: at base line then at the end of the 8 weeks

    Pediatric balance scale The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

  2. 6 Minute walk test (6MWT)

    Time frame: at base line then at the end of the 8 weeks

    endurance measurement

  3. Modified Ashworth scale

    Time frame: at base line then at the end of the 8 weeks

    measuring muscle tone Scoring 0 No Increased in tone

    • Slight increase in tone giving a catch when the limb is moved in flexion or extension 1+ Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM)
    • More marked increase in tone through most of the ROM, but the limb easily flexed
    • Considerable increase in tone, passive movement difficult
    • Limb rigid in flexion or extension

  4. Handheld dynamometer

    Time frame: at base line then at the end of the 8 weeks

    measuring muscles strength

Study contacts

Contact information is provided by the study sponsor or research team.

abdullah owaid Alanazi, PhD student

CONTACT

[email protected]

800-555-5555

alaa ibrahim ismail, professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Lower Limb Constraint-induced Movement Training Versus Strength Training of the Non-hemiplegic Lower Limb on Motor Performance in Children With Hemiplegic Cerebral Palsy: A Randomized Control Trial.

Acronym: NEUROLOGY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

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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