Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Wristbot
Sponsored by

About this trial
This is an interventional diagnostic trial for Stroke
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)
Sites / Locations
- Tan Tock Seng Hospital CART 5B
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wristbot
Arm 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.
Outcomes
Primary Outcome Measures
Fugyl Meyer assessment motor assessment score (FMA 0-66)
To assess motor impairment of affected upper limb
Wolf Motor Function Test for affected limb (WMFT),
To assess motor impairment of affected upper limb
Nine hole peg test (in seconds)
brief, standardized, quantitative test of upper extremity function
Functional Independence Measure
Test of upper limb function
Modified Ashworth Scale
Test of muscle spasticity for upper limb
standardised somatosensory deficit index
Sensory assessment of upper limb
Visual Analogue scale
Scale to assess pain
Secondary Outcome Measures
Full Information
NCT ID
NCT02878759
First Posted
August 17, 2016
Last Updated
October 6, 2020
Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
1. Study Identification
Unique Protocol Identification Number
NCT02878759
Brief Title
Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke
Official Title
Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
July 4, 2019 (Actual)
Study Completion Date
July 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single arm intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wristbot
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Wristbot
Intervention 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.
Primary Outcome Measure Information:
Title
Fugyl Meyer assessment motor assessment score (FMA 0-66)
Description
To assess motor impairment of affected upper limb
Time Frame
2 years
Title
Wolf Motor Function Test for affected limb (WMFT),
Description
To assess motor impairment of affected upper limb
Time Frame
2 years
Title
Nine hole peg test (in seconds)
Description
brief, standardized, quantitative test of upper extremity function
Time Frame
2 years
Title
Functional Independence Measure
Description
Test of upper limb function
Time Frame
2 years
Title
Modified Ashworth Scale
Description
Test of muscle spasticity for upper limb
Time Frame
2 years
Title
standardised somatosensory deficit index
Description
Sensory assessment of upper limb
Time Frame
2 years
Title
Visual Analogue scale
Description
Scale to assess pain
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen SG Chua, MBBS/MRCP
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital CART 5B
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke
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