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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878759
• Other study ID #: 2016/00502
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: July 4, 2019

Study information

• Verified date: October 2020
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 4, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital CART 5B	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

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