Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02592759
• Date of registration: 22/10/2015
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
• Scientific title: Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke
• Date of first enrolment: October 2015
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02592759
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Korea, Republic of

Contacts

• Name: Shi-Uk Lee, MD, PhD
• Affiliation: SMG-SNU Boramae Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke
(ischemic, hemorrhagic, intracranial hemorrhage)

- 72 hours ~ 3 months after stroke

- Upper extremity hemiplegia with Brunnström stage 2-5.

- The patients can sit to receive treatment for at least 1 hour

Exclusion Criteria:

- The patients cannot perform occupational treatments because of severe hemineglect or
hemianopia

- Contracture due to severe limitation of motion

- Upper extremity spasticity in the wrist and fingers with modified Ashworth scale > 2
points

- Fugl-Meyer Assessment-Wrist & Hand score >= 21 points

- moderate to severe cognitive dysfunction < MMSE 18 points

- Severe aphasia

- The patients who has been diagnosed as malignant tumor



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hemiplegia

Stroke

Intervention(s)

Device: Smart Glove Treatment

Primary Outcome(s)

Fugl-Meyer Assessment of Upper Extremity change [Time Frame: Change from baseline points at 2 weeks and 6 weeks]

Secondary Outcome(s)

Modified Barthel Index change [Time Frame: Change from baseline points at 2 weeks and 6 weeks]

Care Burden Scale change [Time Frame: Change from baseline points at 2 weeks and 6 weeks]

Box and Block Test change [Time Frame: Change from baseline points at 2 weeks and 6 weeks]

Brunnström stage change [Time Frame: Change from baseline stage at 2 weeks and 6 weeks]

Jebsen Hand function Test change [Time Frame: Change from baseline points at 2 weeks and 6 weeks]

Hand power change [Time Frame: Change from baseline power at 2 weeks and 6 weeks]

Secondary ID(s)

16-2015-74

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SMG-SNU Boramae Medical Center