Back to resultsEffects of Modified Constraint-Induced on Chronic Stroke Patients
Primary Purpose
Stroke, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
modified constraint-induced therapy
Proprioceptive Training
conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Modified constraint-induced therapy, Proprioceptive Training, conventional rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Post stroke hemiparetic patients of six months
- spasticity ≤ Grade -3 on modified Ashworth scale
- those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
- a score of 24 or higher on the Modified Mini-Mental State Examination
- no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale
Exclusion Criteria:
- Patients with history of previous stroke,
- angina,
- uncontrolled hypertension, on medication that could impair neuromuscular performance,
- wrist or finger pathologies, significant visual or hearing impairment,
- balance problems which may compromise safety during sound upper limb constraint,
- unwilling to participate
Sites / Locations
- Acibadem University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
conventional rehabilitation
Modified constraint-induced therapy
Proprioceptive Training
Arm Description
Outcomes
Primary Outcome Measures
Fugl-Meyer assessment test
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm
Action Research arm test
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm
Motor Activity Log
Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm
Secondary Outcome Measures
Modified Ashworth Scale
Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm
thumb localizing test
A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04873908
Brief Title
Effects of Modified Constraint-Induced on Chronic Stroke Patients
Official Title
Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation
Keywords
Modified constraint-induced therapy, Proprioceptive Training, conventional rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional rehabilitation
Arm Type
Other
Arm Title
Modified constraint-induced therapy
Arm Type
Experimental
Arm Title
Proprioceptive Training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
modified constraint-induced therapy
Intervention Description
Patients received conventional rehabilitation and modified constraint-induced therapy schedule
Intervention Type
Other
Intervention Name(s)
Proprioceptive Training
Intervention Description
Patients received conventional rehabilitation and Proprioceptive Training schedule
Intervention Type
Other
Intervention Name(s)
conventional rehabilitation
Intervention Description
Patients received conventional rehabilitation schedule
Primary Outcome Measure Information:
Title
Fugl-Meyer assessment test
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm
Time Frame
Score change after 6 weeks of intervention compared to baseline
Title
Action Research arm test
Description
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm
Time Frame
Score change after 6 weeks of intervention compared to baseline
Title
Motor Activity Log
Description
Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm
Time Frame
Score change after 6 weeks of intervention compared to baseline
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm
Time Frame
Score change after 6 weeks of intervention compared to baseline
Title
thumb localizing test
Description
A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm.
Time Frame
Score change after 6 weeks of intervention compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post stroke hemiparetic patients of six months
spasticity ≤ Grade -3 on modified Ashworth scale
those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
a score of 24 or higher on the Modified Mini-Mental State Examination
no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale
Exclusion Criteria:
Patients with history of previous stroke,
angina,
uncontrolled hypertension, on medication that could impair neuromuscular performance,
wrist or finger pathologies, significant visual or hearing impairment,
balance problems which may compromise safety during sound upper limb constraint,
unwilling to participate
Facility Information:
Facility Name
Acibadem University
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Modified Constraint-Induced on Chronic Stroke Patients
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