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

NCT02878759 | Completed

• 1 other identifier: 2016/00502
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Wristbot

EXPERIMENTAL

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

Interventions

Wristbot DEVICE

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.

Wristbot

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital CART 5B

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karen SG Chua, MBBS/MRCP

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single arm intervention

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 25, 2016
• Study Start: July 12, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)