Kinect-based Upper Limb Rehabilitation System in Stroke Patients

NCT02066116 | Terminated

• 1 other identifier: B1401-234-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program. In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days. 20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.

Conditions

Stroke; Hemiplegia; Virtual Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks

  Baseline, 2 weeks after the baseline

Secondary Outcomes (4)

• Brunnstrom stage

  Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline

• Modified Barthel Index

  Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline

• Box and Block Test

  Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline

• Number of movement counts during rehabilitation using accelerometer data

  Baseline, 2 weeks after the baseline

Study Arms (2)

Kinect-based Rehabilitation

EXPERIMENTAL

Procedure: Kinect-based rehabilitation plus occupational therapy

Self-exercises education

ACTIVE COMPARATOR

Other: sham virtual rehabilitation education plus occupational therapy

Interventions

Kinect-based rehabilitation plus occupational therapy PROCEDURE

The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.

Kinect-based Rehabilitation

sham virtual rehabilitation education plus occupational therapy OTHER

For the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation.

Self-exercises education

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 20 to 80 years
• Stroke within prior 3 months
• Unilateral upper extremity weakness

You may not qualify if:

• Uncontrolled medical conditions
• Who cannot obey the simple command
• Who has the hemispatial neglect, visual impairment, apraxia

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Microsoft Research: collaborator
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Nam-Jong Paik, MD, PhD

  Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

KR (1)