NCT06520644

Brief Summary

ABSTRACT: Purpose: To investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis. Materials and methods: This study involved 30 children of both sexes with unilateral cerebral palsy aged ranged 8 up to 10 years. A designed physical rehabilitation program was given to both groups. furthermore, study group received a wii fit virtual reality-based program. Muscle strength, bilateral coordination, running speed and agility were assessed by using Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2) while hip and knee extensor strength were assessed by lafayette hand-held dynamometer pre and post treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

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

Study Start

First participant enrolled

November 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 10, 2024

Last Update Submit

July 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2)

    The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21\[9\]. The BOT-2 test consists of four composites and eight subtests including 53 items as follows: Fine manual control (fine motor precision, fine motor integration), Manual coordination (manual dexterity, upper limb coordination), Body Coordination (bilateral coordination, balance), Strength and Agility (running speed and agility, and strength

    through study completion, an average of 1 year

  • Lafayette manual muscle testing system

    commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99

    through study completion ,average of 1 year

Study Arms (2)

Traditional physical therapy program

ACTIVE COMPARATOR

Children in group A (control group N=15, Female =8, Male=7)received specially designed physical therapy program.Facilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board.

Other: Traditional physical therapy program

Traditional physical therapy program and Wii-based interactive training

ACTIVE COMPARATOR

Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training.Children in the study group received the same selected physical therapy program given to the control group in addition to 30 minutes Wii-based interactive training program. The frequency of the whole program will be three times per week, for three months. Nintendo Wii video game consists of console, remote, nunchuck and balance board. The Wii gaming system is based on wireless controller.The games used in this study include step basic, hula hoop, table tilt, jogging, jumping, single limb extension.

Device: Wii-based interactive training programOther: Traditional physical therapy program

Interventions

include step basic, hula hoop, table tilt, jogging, jumping, single limb extension. Single limb extension

Traditional physical therapy program and Wii-based interactive training

Facilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board.

Traditional physical therapy programTraditional physical therapy program and Wii-based interactive training

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 8-10 years old
  • Children were included in the study had Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale\[15\].
  • Motor skill level was at level I and II according to Gross Motor Function Classification System GMFCS\[16\].
  • Able to follow instructions during evaluation and treatment

You may not qualify if:

  • Children were excluded from the study had Cardiovascular or respiratory disorders.
  • Botulinium muscular injection in the last 6 months.
  • Surgical interference in lower limbs and/or spine.
  • Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
  • Seizures
  • Visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israa Ahmed Mohamed Shawki

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a randomized controlled trial (RCT) as the selected children were divided randomly by sealed envelopes into two groups of equal number 15 children for each group. The investigator prepared 30 closed envelopes, with each envelope containing a card labeled as either group A or B. Each child legal guardian was asked to draw a closed envelope that determined whether he/she was allocated to Children in group A (control group N=15, Female =8, Male=7) received specially designed physical therapy program. Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training. The sample size for this study was calculated using the G\*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of Physical Therapy Department for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 25, 2024

Study Start

November 10, 2021

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations