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

NCT03268304 | Withdrawn

• 1 other identifier: KAYO
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• cARAT

  Score on the conventional Action Research Arm Test

  17 weeks

• dARAT

  score on the digital ARAT

  17 weeks

• SUS

  System Usability Scale questionnaire

  15 weeks

Secondary Outcomes (4)

• BBT

  17 weeks

• CAHAI

  17 weeks

• EQ-5D-5L

  17 weeks

• PGIC

  11 weeks

Interventions

VR-based training including AO and MI OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reha Rheinfelden: lead

Related Publications (1)

• 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.

  PMID: 30012780 DERIVED

MeSH Terms

Conditions

Stroke; Parkinson Disease; Brain Injuries, Traumatic; Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Behrendt, PhD

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

• Corina Schuster, PhD

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: November 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: May 30, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04