Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03268304
Recruitment Status : Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Frank Behrendt, Reha Rheinfelden

Brief Summary:

Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process.

Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients & methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).

Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.


Condition or disease Intervention/treatment
Stroke Parkinson Disease Traumatic Brain Injury Guillain-Barre Syndrome Other: VR-based training including AO and MI

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System — the KAYO Study Protocol
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018



Intervention Details:
  • Other: VR-based training including AO and MI
    Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device


Primary Outcome Measures :
  1. cARAT [ Time Frame: 17 weeks ]
    Score on the conventional Action Research Arm Test

  2. dARAT [ Time Frame: 17 weeks ]
    score on the digital ARAT

  3. SUS [ Time Frame: 15 weeks ]
    System Usability Scale questionnaire


Secondary Outcome Measures :
  1. BBT [ Time Frame: 17 weeks ]
    Box and Block Test

  2. CAHAI [ Time Frame: 17 weeks ]
    Chedoke McMaster Arm and Hand Activity Inventory

  3. EQ-5D-5L [ Time Frame: 17 weeks ]
    EuroQol five dimensions questionnaire with five-level scale

  4. PGIC [ Time Frame: 11 weeks ]
    Patient Global Impression of change



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
  1. Patients will be recruited from the clinics' inpatient or outpatient departments by physicians, therapists and nurses.
  2. Patients will be recruited from the clinics' patient database. Datasets will be screened for study selection criteria by the involved study personnel. If patients are eligible, they will be sent a letter describing the study and including patient information. If patients are interested in participating, they can contact the study personnel in the clinic by phone or email.
  3. Patients will be recruited via a study information flyer provided on the clinic's homepage and through patient self-help groups. If patients are interested in participating, they can contact the study personnel in the responsible clinic by phone or email.
Criteria

Inclusion Criteria:

  • Patients with motor function impairments of one or both upper limbs caused by Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome
  • Able to sit in a normal chair without armrests
  • Able to score at least one in the Box and Block Test (BBT)
  • Comprehend German
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture
  • Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20
  • Severe spatial-visual disorders, e.g. severe visual neglect
  • History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment
  • Brain pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268304


Contacts
Layout table for location contacts
Contact: Frank Behrendt, PhD +41 61 836 53 81 f.behrendt@reha-rhf.ch
Contact: Corina Schuster, PhD +41 61 836 53 81 c.schuster@reha-rhf.ch

Sponsors and Collaborators
Reha Rheinfelden
Investigators
Layout table for investigator information
Principal Investigator: Frank Behrendt, PhD Reha Rheinfelden
Principal Investigator: Corina Schuster, PhD Reha Rheinfelden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Frank Behrendt, Principal Investigator, Reha Rheinfelden
ClinicalTrials.gov Identifier: NCT03268304     History of Changes
Other Study ID Numbers: KAYO
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Frank Behrendt, Reha Rheinfelden:
Upper Limb Motor Function Deficit
Neurorehabilitation
Virtual Reality
Action Research Arm Test

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Parkinson Disease
Guillain-Barre Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases