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

NCT ID: NCT03268304

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-05-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

VR-based training including AO and MI

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reha Rheinfelden

OTHER

Sponsor Role: lead

Responsible Party

Frank Behrendt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Behrendt, PhD

Role: PRINCIPAL_INVESTIGATOR

Reha Rheinfelden

Corina Schuster, PhD

Role: PRINCIPAL_INVESTIGATOR

Reha Rheinfelden

References

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.

Reference Type: DERIVED

PMID: 30012780 (View on PubMed)

Other Identifiers

KAYO

Identifier Type: -

Identifier Source: org_study_id