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

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ClinicalTrials.gov Identifier: NCT03268304
Recruitment Status : Unknown
Verified September 2017 by Frank Behrendt, Reha Rheinfelden.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Frank Behrendt, Reha Rheinfelden

Tracking Information
First Submitted Date August 29, 2017
First Posted Date August 31, 2017
Last Update Posted Date September 26, 2017
Estimated Study Start Date November 2017
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2017)
  • cARAT [ Time Frame: 17 weeks ]
    Score on the conventional Action Research Arm Test
  • dARAT [ Time Frame: 17 weeks ]
    score on the digital ARAT
  • SUS [ Time Frame: 15 weeks ]
    System Usability Scale questionnaire
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03268304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 30, 2017)
  • BBT [ Time Frame: 17 weeks ]
    Box and Block Test
  • CAHAI [ Time Frame: 17 weeks ]
    Chedoke McMaster Arm and Hand Activity Inventory
  • EQ-5D-5L [ Time Frame: 17 weeks ]
    EuroQol five dimensions questionnaire with five-level scale
  • PGIC [ Time Frame: 11 weeks ]
    Patient Global Impression of change
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Stroke
  • Parkinson Disease
  • Traumatic Brain Injury
  • Guillain-Barre Syndrome
Intervention Other: VR-based training including AO and MI
Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device
Study Groups/Cohorts Not Provided
Publications * Behrendt F, Schuster-Amft C. Using an interactive virtual environment to integrate a digital Action Research Arm Test, motor imagery and action observation to assess and improve upper limb motor function in patients with neuromuscular impairments: a usability and feasibility study protocol. BMJ Open. 2018 Jul 16;8(7):e019646. doi: 10.1136/bmjopen-2017-019646.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 30, 2017)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03268304
Other Study ID Numbers KAYO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Frank Behrendt, Reha Rheinfelden
Study Sponsor Reha Rheinfelden
Collaborators Not Provided
Investigators
Principal Investigator: Frank Behrendt, PhD Reha Rheinfelden
Principal Investigator: Corina Schuster, PhD Reha Rheinfelden
PRS Account Reha Rheinfelden
Verification Date September 2017