Kinect-based Upper Limb Rehabilitation System in Stroke Patients

Stroke Clinical Trial

Official title:

Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02066116
• Other study ID #: B1401-234-001
• Status: Terminated
• Phase: N/A
• First received: February 13, 2014
• Last updated: November 1, 2017
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age from 20 to 80 years

• Stroke within prior 3 months

• Unilateral upper extremity weakness

Exclusion Criteria:

• Uncontrolled medical conditions

• Who cannot obey the simple command

• Who has the hemispatial neglect, visual impairment, apraxia

Related Conditions & MeSH terms

• Hemiplegia
• Stroke
• Virtual Rehabilitation

Intervention

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

Other:
• sham virtual rehabilitation education plus occupational therapy
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seongnam	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Microsoft Research, The Ministry of Science, ICT and Future Planning, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks		Baseline, 2 weeks after the baseline
Secondary	Brunnstrom stage	This is composed of 6 stages. Higher score means better function. The description for each stage as follows.; Flaccidity: no voluntary movement.; Synergies or minimal voluntary movement.; Synergies performed voluntary (spasticity gratest).; Some deviation from synergy.; Independent or isolated movement.; Individual joint movement nearly normal with minimal spasticity.	Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Secondary	Modified Barthel Index		Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Secondary	Box and Block Test	Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition.; One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.; The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.; The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.	Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Secondary	Number of movement counts during rehabilitation using accelerometer data		Baseline, 2 weeks after the baseline

External Links

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