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Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy

Primary Purpose

Cerebral Palsy, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VGBT with Nintendo® Wii and LMC games
NDT-based upper limb rehabilitation
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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"

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VGBT with Nintendo® Wii and LMC games

    NDT-based upper limb rehabilitation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Modified Ashworth Scale
    Modified Ashworth Scale (MAS) measures the muscle spasticity rate (score, 0-5). Spasticity of wrist flexors, elbow flexors and forearm pronators will be assessed due to MAS in this study. Participants sat with their forearm fully supported and will be instructed to relax. The measurer moves the wrist into extension as fast as possible and then rated the quality of the muscle reaction to stretch on a scale from 0 to 5, with 0 representing no spasticity.
    Hand and pinch grips
    Grip strength was measured using a standard adjustable handle Jamar® Plus+Hand Dynamometer (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch strengths (tip, key and palmar pinch) will be measured by a hydraulic pinch gauge (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch positions will be defined using the American Society for Hand Therapists guideline. Each of grip and pinch strength tests will be performed thrice with a 30-sec interval between tests, and the mean value will be recorded.

    Full Information

    First Posted
    July 22, 2018
    Last Updated
    November 3, 2018
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03622970
    Brief Title
    Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
    Official Title
    Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 3, 2015 (Actual)
    Primary Completion Date
    August 13, 2018 (Actual)
    Study Completion Date
    August 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    The investigators hypothesized that VGBT using the Nintendo® Wii and LMC would be a usable tool to train manual dexterity in patients with CP as comprehensive and holistic therapy. The NDT program for both groups will be routinely applied according to each child's individual needs and included tonus regulation, support of sensation, perception and motor development for gross motor function. The two different patient-centered rehabilitation programs will be conducted with an average of one hour sessions three times a week for 8 weeks in both groups. The two different patient-centered programs will be as VGBT with Nintendo® Wii and LMC games (Group I) and NDT-based upper limb rehabilitation (Group II).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VGBT with Nintendo® Wii and LMC games
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    NDT-based upper limb rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    VGBT with Nintendo® Wii and LMC games
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    NDT-based upper limb rehabilitation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Minnesota Hand Dexterity Test
    Description
    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.
    Time Frame
    Change from baseline to 8 weeks, follow up at two months
    Secondary Outcome Measure Information:
    Title
    Modified Ashworth Scale
    Description
    Modified Ashworth Scale (MAS) measures the muscle spasticity rate (score, 0-5). Spasticity of wrist flexors, elbow flexors and forearm pronators will be assessed due to MAS in this study. Participants sat with their forearm fully supported and will be instructed to relax. The measurer moves the wrist into extension as fast as possible and then rated the quality of the muscle reaction to stretch on a scale from 0 to 5, with 0 representing no spasticity.
    Time Frame
    Change from baseline to 8 weeks, follow up at two months
    Title
    Hand and pinch grips
    Description
    Grip strength was measured using a standard adjustable handle Jamar® Plus+Hand Dynamometer (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch strengths (tip, key and palmar pinch) will be measured by a hydraulic pinch gauge (Irvington NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90. Pinch positions will be defined using the American Society for Hand Therapists guideline. Each of grip and pinch strength tests will be performed thrice with a 30-sec interval between tests, and the mean value will be recorded.
    Time Frame
    Change from baseline to 8 weeks, follow up at two months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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" Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy

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