NCT04533789

Brief Summary

The children with hemiplegic cerebral palsy had a longer gait cycle, slower walking speed, and longer support phase than did the healthy children. The support phase was longer than the swing phase in the children with hemiplegic cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 16, 2020

Last Update Submit

August 26, 2020

Conditions

Keywords

wii sporttask oriented traininghemiplegic cerebral palsy

Outcome Measures

Primary Outcomes (6)

  • cadence (number)

    number of steps in each min.

    cadence assessed at day 0.

  • cadence (number)

    number of steps in each min.

    cadence assessed at day 90.

  • step length of affected side (cm)

    distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)

    step length assessed at day 0.

  • step length of affected side (cm)

    distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)

    step length assessed at day 90.

  • stride length of affected side(cm)

    the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)

    stride length assessed at day 0.

  • stride length of affected side(cm)

    the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position). (cm)

    stride length assessed at day 90.

Study Arms (3)

the control group

EXPERIMENTAL

Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment.

Other: selected physical therapy program

virtual reality

EXPERIMENTAL

Group 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min.

Other: selected physical therapy program

Task oriented

EXPERIMENTAL

Group 3 the study group received the same physical therapy program 30 min. plus task oriented training for 30 min.

Other: selected physical therapy program

Interventions

strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors

Task orientedthe control groupvirtual reality

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will ranging from 7 to 9 years.
  • Children participated in this study will from both sexes.
  • Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
  • All children will able to walk supported or unsupported by the therapist.
  • Children will able to follow the instructions during testing and training.
  • All children had no fixed contractures or deformities at the lower limb.

You may not qualify if:

  • Children with visual or auditory problems.
  • Children with history of epilepsy.
  • Children with structural joints deformities of the lower limbs.
  • Children with history of surgical interference in lower limbs less than one year.
  • Children with convulsions and fixed contractures.
  • Uncooperative children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location

Related Publications (4)

  • Wang X, Wang Y. Gait analysis of children with spastic hemiplegic cerebral palsy. Neural Regen Res. 2012 Jul 15;7(20):1578-84. doi: 10.3969/j.issn.1673-5374.2012.20.008.

    PMID: 25657696BACKGROUND
  • Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.

    PMID: 19932621BACKGROUND
  • Grasso R, Assaiante C, Prevost P, Berthoz A. Development of anticipatory orienting strategies during locomotor tasks in children. Neurosci Biobehav Rev. 1998 Jul;22(4):533-9. doi: 10.1016/s0149-7634(97)00041-9.

    PMID: 9595566BACKGROUND
  • Gatica-Rojas V, Mendez-Rebolledo G, Guzman-Munoz E, Soto-Poblete A, Cartes-Velasquez R, Elgueta-Cancino E, Cofre Lizama LE. Does Nintendo Wii Balance Board improve standing balance? A randomized controlled trial in children with cerebral palsy. Eur J Phys Rehabil Med. 2017 Aug;53(4):535-544. doi: 10.23736/S1973-9087.16.04447-6. Epub 2016 Nov 24.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mohammed E Ali, PhD student

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (virtual reality group), group 3 (task oriented training)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: G 1 (control) received traditional physical therapy program for 60 min. G 2 (study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and task oriented training for 30 min. all groups treated for four successive months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy

Study Record Dates

First Submitted

August 16, 2020

First Posted

September 1, 2020

Study Start

May 22, 2019

Primary Completion

May 22, 2020

Study Completion

July 29, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations