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

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

Sponsors

Lead sponsor: Tan Tock Seng Hospital

Collaborator: Nanyang Technological University

Source Tan Tock Seng Hospital
Brief Summary

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.

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.

Overall Status Unknown status
Start Date August 2016
Completion Date September 2018
Primary Completion Date September 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fugyl Meyer assessment motor assessment score (FMA 0-66) 2 years
Wolf Motor Function Test for affected limb (WMFT), 2 years
Nine hole peg test (in seconds) 2 years
Functional Independence Measure 2 years
Modified Ashworth Scale 2 years
standardised somatosensory deficit index 2 years
Visual Analogue scale 2 years
Enrollment 50
Condition
Intervention

Intervention type: Device

Intervention name: Wristbot

Description: 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.

Arm group label: Wristbot

Eligibility

Criteria:

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)

Gender: All

Minimum age: 21 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Karen SG Chua, MBBS/MRCP Principal Investigator Tan Tock Seng Hospital
Overall Contact

Last name: Karen SG Chua, MBBS / MRCP

Phone: 6256 6011

Email: [email protected]

Location
facility Tan Tock Seng Hospital CART 5B
Location Countries

Singapore

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Wristbot

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov