NCT03622970

Brief Summary

The aim of the present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP).

Trial Health

100
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 Mar 2015

Longer than P75 for not_applicable

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

March 3, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

July 22, 2018

Last Update Submit

November 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Minnesota Hand Dexterity Test

    Minnesota Manual Dexterity Test (MMDT): is a short version of the Minnesota Dexterity Tests and consists of two timed sub-tests ("placing" and "turning tests") to assess the required manual dexterity to turn and/or place 60 short, round blocks with one or both hands . In this study, the placing sub-test will be used to assess the ability to handle objects, measured by the time required to complete the task.

    Change from baseline to 8 weeks, follow up at two months

Secondary Outcomes (2)

  • Modified Ashworth Scale

    Change from baseline to 8 weeks, follow up at two months

  • Hand and pinch grips

    Change from baseline to 8 weeks, follow up at two months

Study Arms (2)

VGBT with Nintendo® Wii and LMC games

EXPERIMENTAL

VGBT with Nintendo® Wii and LMC games: In order to improve the elbow and shoulder functions, Tennis and boxing, the games of Nintendo Wii® Fit WiiSports package that includes shoulder and elbow movements will be used for VGBT with Nintendo® Wii and Leap Motion Controller (LMC) games. In both of the games, the activities are carried out by providing feedback in the context of remote control and sound and vibration notifications.

Device: VGBT with Nintendo® Wii and LMC games

NDT-based upper limb rehabilitation

ACTIVE COMPARATOR

NDT-based upper limb rehabilitation: NDT-based upper limb rehabilitation aims to facilitate normal movement for upper extremity activities such as getting dressed and eating etc by using real materials (clothes, spoons, pencils, buttons, rope, etc.). The target activities were practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.

Behavioral: NDT-based upper limb rehabilitation

Interventions

Nintendo Wii and LMC games will be used for upper limb rehabilitation in Cerebral Palsy. The games are tennis and boxing for Nintendo Wii, Leapball and CatchApet for LMC.

VGBT with Nintendo® Wii and LMC games

NDT-based upper limb rehabilitation includes using real materials (clothes, spoons, pencils, buttons, rope, etc.) such as getting dressed and eating etc. Also, It will practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.

NDT-based upper limb rehabilitation

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The health committee report has received a CP diagnosis
  • Being between 5-18 years of age
  • According to Modifiye Ashworth Scale (MAS), upper extremity spasticity (0), (1), (1+)
  • Ability to adapt to exercises (According to the health report mental level normal or "mild mental retardation"

You may not qualify if:

  • Botulinium Toxin (BOTOX) injection for the upper extremity in the last 6 months
  • Does not have epileptic epilepsy
  • Any person who has been diagnosed as having any absence of a cardiac or orthopedic condition
  • Admission of family treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 9, 2018

Study Start

March 3, 2015

Primary Completion

August 13, 2018

Study Completion

August 23, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11