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

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ClinicalTrials.gov Identifier: NCT02878759
Recruitment Status : Not yet recruiting
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Nanyang Technological University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Wristbot Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke.
Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

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.




Primary Outcome Measures :
  1. Fugyl Meyer assessment motor assessment score (FMA 0-66) [ Time Frame: 2 years ]
    To assess motor impairment of affected upper limb

  2. Wolf Motor Function Test for affected limb (WMFT), [ Time Frame: 2 years ]
    To assess motor impairment of affected upper limb

  3. Nine hole peg test (in seconds) [ Time Frame: 2 years ]
    brief, standardized, quantitative test of upper extremity function

  4. Functional Independence Measure [ Time Frame: 2 years ]
    Test of upper limb function

  5. Modified Ashworth Scale [ Time Frame: 2 years ]
    Test of muscle spasticity for upper limb

  6. standardised somatosensory deficit index [ Time Frame: 2 years ]
    Sensory assessment of upper limb

  7. Visual Analogue scale [ Time Frame: 2 years ]
    Scale to assess pain



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878759


Contacts
Contact: Karen SG Chua, MBBS / MRCP 6256 6011 karen_chua@ttsh.com.sg

Locations
Singapore
Tan Tock Seng Hospital CART 5B
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Nanyang Technological University
Investigators
Principal Investigator: Karen SG Chua, MBBS/MRCP Tan Tock Seng Hospital

Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT02878759     History of Changes
Other Study ID Numbers: 2016/00502
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases