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Completed

NCT Number: NCT03622970

Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Rehabilitation

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

VGBT with Nintendo® Wii and LMC games

Device

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.

NDT-based upper limb rehabilitation

Behavioral

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 outcomes

  1. Minnesota Hand Dexterity Test

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

    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 outcomes

  1. Modified Ashworth Scale

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

    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.

  2. Hand and pinch grips

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

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Nov 6, 2018

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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