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WithdrawnNCT03268304Updated Apr 21, 2020

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

An observational study in Stroke, Parkinson Disease and Traumatic Brain Injury, sponsored by Reha Rheinfelden. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Reha Rheinfelden · Observational

Why this study was withdrawn
The software modules were not completed.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Parkinson Disease
  • Traumatic Brain Injury
  • Guillain-Barre Syndrome

Keywords

  • Upper Limb Motor Function Deficit
  • Neurorehabilitation
  • Virtual Reality
  • Action Research Arm Test
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherVR-based training including AO and MI

    Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device

05

What researchers measure

Primary outcomes

  1. cARAT

    Score on the conventional Action Research Arm Test

    Time frame: 17 weeks

  2. dARAT

    score on the digital ARAT

    Time frame: 17 weeks

  3. SUS

    System Usability Scale questionnaire

    Time frame: 15 weeks

Secondary outcomes

  1. BBT

    Box and Block Test

    Time frame: 17 weeks

  2. CAHAI

    Chedoke McMaster Arm and Hand Activity Inventory

    Time frame: 17 weeks

  3. EQ-5D-5L

    EuroQol five dimensions questionnaire with five-level scale

    Time frame: 17 weeks

  4. PGIC

    Patient Global Impression of change

    Time frame: 11 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 30012780 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03268304
Lead sponsor
Reha Rheinfelden
Responsible party
Frank Behrendt (Principal Investigator, Reha Rheinfelden) — Principal investigator
First posted
Aug 31, 2017
Start date
Nov 1, 2018
Primary completion
Apr 1, 2020
Completion
May 30, 2020 (estimated)
Last update
Apr 21, 2020

Study contacts

Frank Behrendt, PhD
principal investigator · Reha Rheinfelden
Corina Schuster, PhD
principal investigator · Reha Rheinfelden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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