Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke

Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke.

The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Wristbot

Detailed Description

The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease. It has been validated in three clinical trials, including orthopaedic patients, Parkinsons disease and 9 chronic stroke patients. Its unique feature uses adaptive, progressive robot-aided therapy to achieve intensive, task specific wrist movements.

In the context of the proposed project we will target the stroke population. Integration refers here to the system's ability to perform the assessment of proprioceptive status and proprioceptive training in a single device. The scope of the current project is investigating the efficacy of the proprioceptive assessment of the WristBot and correlating the result throughout the rehabilitation protocol. The proposed technology comprises a hardware device with four motors that can apply torques to the human wrist about its three degrees of freedom (i.e. axes of rotation: wrist flexion/extension,abduction/adduction and forearm pronation/supination). This allows for guided and controlled movements of the wrist by delivering assistive, resistive, perturbation or no forces (patient actively moves the wrist). It contains a set of specialized software modules that a) allow for the objective, psychophysical assessment of sensory dysfunction in patients, and b) provide specialized training modules designed to improve sensory and motor functions of the wrist.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital CART 5B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First clinical stroke (ischaemic or haemorrhagic) diagnosed by brain imaging CT or MRI
• Age 21 years to 85 years, both males and females.
• < 90 days of stroke on admission to rehabilitation
• Presence of either motor and /or sensory deficit detected by clinical examination.
• Ability to understand simple instructions.
• Ability to give own consent.
• Ability to sit supported in a chair for 60 minutes with appropriate rest breaks.

Exclusion Criteria:

• Non stroke -related causes of motor/sensory deficits
• Tetraplegia or tetraparesis
• Known diagnosis of cervical myelopathy, lower motor neuron weakness (Post polio, brachial plexopathy, peripheral neuropathy (Diabetic, carpel tunnel syndrome, B12 deficiency)
• Concomitant orthopaedic condition limiting wrist range of motion: active arm/wrist fractures, fixed contractures of the wrist joint, wrist joint arthritis, wrist fusion.
• Arm or wrist joint pain (Visual Analogue scale VAS >5/10) or instability
• Severe hemispatial neglect.
• Significant wrist spasticity with modified Ashworth Scale score 2 and above.
• Life expectancy <6 months, end stage renal or liver disease, terminal cancer.
• Pregnancy and lactation in female patients.
• Postural hypotension on sitting up
• Active skin conditions over wrist joint area which could be worsened by robotic fit (e.g. severe eczema, burns)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Wristbot; WristBot will be used as diagnostic tool to evaluate the novel technology and the associated protocol for proprioception quantification during rehabilitation. The main objective is to provide clinicians with a reliable instrument able to overcome the limitations in proprioceptive measurement by current clinical methodologies.

Device: Wristbot; The proposed technology comprises a hardware device with four motors that can apply torques to the human wrist about its three degrees of freedom (i.e. axes of rotation: wrist flexion/extension,abduction/adduction and forearm pronation/supination). This allows for guided and controlled movements of the wrist by delivering assistive, resistive, perturbation or no forces (patient actively moves the wrist). It contains a set of specialized software modules that a) allow for the objective, psychophysical assessment of sensory dysfunction in patients, and b) provide specialized training modules designed to improve sensory and motor functions of the wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugyl Meyer assessment motor assessment score (FMA 0-66)	To assess motor impairment of affected upper limb	2 years
Wolf Motor Function Test for affected limb (WMFT),	To assess motor impairment of affected upper limb	2 years
Nine hole peg test (in seconds)	brief, standardized, quantitative test of upper extremity function	2 years
Functional Independence Measure	Test of upper limb function	2 years
Modified Ashworth Scale	Test of muscle spasticity for upper limb	2 years
standardised somatosensory deficit index	Sensory assessment of upper limb	2 years
Visual Analogue scale	Scale to assess pain	2 years

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Karen SG Chua, MBBS/MRCP, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2018
• Primary Completion (ACTUAL): July 4, 2019
• Study Completion (ACTUAL): July 4, 2019

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 21, 2016
• First Posted (ESTIMATE): August 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016/00502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No