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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02878759
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: Tan Tock Seng Hospital
• Public title: Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke
• Scientific title: Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke.
• Date of first enrolment: July 12, 2018
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02878759
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Karen SG Chua, MBBS/MRCP
• Affiliation: Tan Tock Seng Hospital

Key inclusion & exclusion 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)



Age minimum: 21 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Device: Wristbot

Primary Outcome(s)

Fugyl Meyer assessment motor assessment score (FMA 0-66) [Time Frame: 2 years]

Visual Analogue scale [Time Frame: 2 years]

Functional Independence Measure [Time Frame: 2 years]

Modified Ashworth Scale [Time Frame: 2 years]

Nine hole peg test (in seconds) [Time Frame: 2 years]

standardised somatosensory deficit index [Time Frame: 2 years]

Wolf Motor Function Test for affected limb (WMFT), [Time Frame: 2 years]

Secondary ID(s)

2016/00502

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nanyang Technological University