NCT02764372

Brief Summary

The aims of the present study were to:

  • Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services.
  • Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS. Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_1 multiple-sclerosis

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

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

May 3, 2016

Last Update Submit

May 5, 2016

Conditions

Multiple SclerosisStroke

Keywords

Arm rehabilitationSerious gamesstrokeMultiple sclerosis

Outcome Measures

Primary Outcomes (2)

  • 9 Hole peg test

    Testing pre and post intervention

    10 months

  • Box and Block test

    Testing pre and post intervention

    10 months

Secondary Outcomes (2)

  • Short Form 12

    10 months

  • the EQ-5D visual analogue scale (EQ-VAS)

    10 months

Study Arms (2)

Serious games

EXPERIMENTAL

The experimental group received Serious Games-based upper extremity therapy through Kinect

Behavioral: Serious games

Exergames

ACTIVE COMPARATOR

The control played the same amount of time with commercial exergames of the Wii

Behavioral: Exergames

Interventions

Serious gamesBEHAVIORAL

Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113

Also known as: virtual reality games
Serious games
ExergamesBEHAVIORAL

Participants played exergames existent in the Wii game console

Also known as: Wii game console
Exergames

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons Post stroke or with MS with resultant upper extremity motor deficits.
  • Range of motion of shoulder and elbow equal or higher than 45 degrees.
  • Able to comprehend and follow directions.

You may not qualify if:

  • Wearing pace maker
  • Comorbidities affecting arm use
  • Not able to comprehend and follow directions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisStroke

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 6, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05