Rhythmic-Based Training With Immersive Mirror Visual Feedback for Neuro-Rehabilitation

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06056219
Collaborator
(none)
36
1
2
14.1
2.6

Study Details

Study Description

Brief Summary

In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Mirror therapy
  • Device: Virtual reality-based mirror therapy with rhythmic skill training
  • Other: Task-oriented training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Rhythmic-Based Training With Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mirror therapy using a mirror box

30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training

Device: Mirror therapy
30 minutes' mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise of less-affected upper extremity using a mirror box

Other: Task-oriented training
20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient

Experimental: Virtual reality-based mirror therapy with rhythmic skill training

30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training

Device: Virtual reality-based mirror therapy with rhythmic skill training
30 minutes' virtual reality-based mirror therapy with rhythmic skill training included musical exercises involving virtual drums playing with less-affected upper extremity, and synchronized virtual drums playing and singing activity

Other: Task-oriented training
20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient

Outcome Measures

Primary Outcome Measures

  1. Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test [baseline, 9 weeks and 21 weeks]

    Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The motor performance score ranges from 0 to 66 for the upper extremity.

Secondary Outcome Measures

  1. Change in the result of Box and block test [baseline, 9 weeks and 21 weeks]

    The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. The minimum and maximum value is 0 and 150 respectively.

  2. Change in the result of Modified Ashworth scale (MAS) [baseline, 9 weeks and 21 weeks]

    Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion (ROM); 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.

  3. Change in the result of Semmes-Weinstein monofilament (SWM) test [baseline, 9 weeks and 21 weeks]

    The Semmes-Weinstein monofilament test examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome

  4. Change in the result of Motor Activity Log [baseline, 9 weeks and 21 weeks]

    Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 activities of daily living. Score range from 0-5. Higher values represent a better outcome

Other Outcome Measures

  1. functional Magnetic Resonance Imaging [baseline, 9 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Clinical diagnosis of stroke with unilateral side involved;

  • A score of Mini-mental state examination greater than 24 for proving higher mental function

  • Time of onset > 6 months before treatment begins; and

  • Premorbid right-handedness.

Exclusion Criteria:
  • Severe vision and hearing impairment;

  • Major cognitive-perceptual deficit;

  • Other brain disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng-Kung University Hospital Tainan Taiwan ˙704

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT06056219
Other Study ID Numbers:
  • B-ER-112-174
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 28, 2023