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Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Modified Constraint Induced Therapy and Threshold Electrical Stimulation
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, Electrical stimulation, Upper extremity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stroke patients aged between 18-80 years
  • Having had a stroke at least 3 months and at most 24 months ago
  • Having an active range of motion of the upper extremity which is stated below:

Shoulder flexion and abduction of at least 45 degrees Starting from a 90° flexion position, at least 20° elbow extension Starting from full of wrist flexion position at least 20° wrist extension At least 10° of extension at the metacarpophalangeal and interphalangeal joints of all fingers

- Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤2 according to the Modified Ashworth Scale)

Exclusion Criteria:

  • Uncontrollable arrhythmia and/or hypertension
  • Presence of advanced sensory deficit
  • Visual and hearing problems
  • Presence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity >2 according to the Modified Ashworth Scale)

Sites / Locations

  • Emel Mete

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group-1 (M-CIMT group)

Experimental group-2 (M-CIMT+TES group)

Control group

Arm Description

participants in this group will be trained with Modified Constraint Induced Therapy (M-CIMT) in addition to conventional therapy. M-CIMT is shorter versions of CIMT. The original CIMT devotes six or more hours for therapy and constraining of the intact arm for 90% of waking hours per day and over a period of two weeks. Researchers have observed that such a schedule of CIMT is exhaustive and possibly resulting in non-compliance. Because of this reason,s Modified shorter versions of CIMT (mCIMT) have been designed by researchers. Duration of M-CIMT interventions varies from 2 to 10 weeks and the treatment time also varies from as short as 30 minutes to three hours per day in various studies. Nevertheless both CIMT and mCIMT have shown promising success. M-CIMT emphasizes massed practice with the affected upper limb.

participants in this group will be trained with Modified Constraint Induced Therapy (M-CIMT) and threshold electrical stimulation (TES) in addition to conventional therapy. TES is based on low-intensity (<100 Hz) and long-duration current and is applied with superficial electrodes. TES provides a natural proprioception by depolarizing the sensory and motor nerves without causing any muscle contraction. TES can improve motor learning and motor performance by improving connections between sensory-motor cortical association regions in the brain.

participants in this group will be trained with conventional therapy. Conventional therapy consists of strength training, stretching exercises and functional activity training.

Outcomes

Primary Outcome Measures

Range of motion (ROM) of upper extremity
A universal goniometer will be used to evaluate ROM (shoulder flexion and abduction, elbow flexion and extension, wrist flexion and extension and extension of fingers). Kendall-McCreary criteria will be considered in the assessments. Measurements will be repeated three times and the average value will be used in the statistical analysis.
Pain of upper extremity
Pain (pain of shoulder, elbow, wrist and fingers) will be evaulated with VAS (Visual Analog Scale). The VAS consists of a 10 cm straight line which presents a continuum of intensity and has verbal anchors at opposite ends representing 'no pain' at the bottom and 'pain as bad as it can be' at the top. The participants will be asked to mark the representing point of their pain levels. The values will be recorded in centimeters.
Muscle tone and viscoelastic properties of muscle:
Muscle tone will be evaluated with the Myoton®PRO Digital Palpation Device. It is an evidence-based Class 1 device that evaluates the bio-mechanical properties of soft biological tissues in a non-invasive, objective, reliable, inexpensive, quick and easy way. Myoton® PRO is used in research to evaluate superficial skeletal muscles, connective tissues such as tendons and ligaments, and other soft tissues
Severity of spasticity
The Modified Tardieu scale will be used to assess the severity of spasticity. In this method, the severity of spasticity is evaluated at different rates determined. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion. The Stretching Velocities are as follows: V1: As slow as possible (slower than the gravity fall speed of the limb segment) V2: At the rate of gravity fall of the limb V3: As fast as possible (faster than the normal gravity fall speed of the limb).
Superficial sensory function
The Semmes Weinstein monofilament test battery will be used to evaluate the superficial sense of upper extremity. Monofilaments of varying thickness between 1.65 and 6.65 are used in this test battery. The evaluator applies in order from the smallest filament to the largest filament, the test is stopped when the monofilament is detected by the evaluator. It is a reliable method used in the superficial sensory evaluation of stroke patients.
Health-Related Quality Of Life
"Stroke-specific quality of life scale (SSQOL)" will be used to evaluate quality of life. SSQOL; It is a valid and reliable scale consisting of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and productivity, and a total of 49 questions. It is graded with Likert-type scoring ranging from 1 to 5.
Functional Status
Wolf Motor Function test is used to evaluate upper extremity motor functions. For 15 activities, data is collected in 2 areas, "Functional Skill" and "Performance Time". Using the "Functional Skills Scale", each activity is evaluated between 0-5 points (0= Never used the affected hand during the activity, 5= Normal movement). The average score is calculated for the Functional Skill Scale. Performance Time" is recorded in seconds (sec).
Motor activity
Motor activity diary-28 (MAG-28) will be used to evaluate motor activity. The MAG-28 is a valid and reliable scale designed to examine how often and how well a person uses their affected arm outside of the treatment session. It consists of two scales that question how often the patient uses the affected side upper extremity for each activity during daily activities (turning the light switch, opening the door, etc.) (Use Frequency Scale), and if so, how well he or she can perform the activity (Movement Quality Scale). The patient scores himself between 0 and 5 (0 = I do not use my affected arm at all, 5 = I use my affected arm with the same frequency/quality as before the stroke). For the average score, the total scores of both scales are calculated separately and divided by the number of questions

Secondary Outcome Measures

Full Information

First Posted
September 30, 2021
Last Updated
August 21, 2023
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05076123
Brief Title
Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients
Official Title
Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet 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
This study, it is aimed to investigate the effectiveness of applied modified constraint-induced movement therapy (MCIMT) with threshold electrical stimulation (TES) in addition to conventional therapy (therapeutic exercise program) in patients with stroke. Before and after the treatment program we will evaluate, the pain level of the participants measured with a visual pain scale; sensory functions with Semmes Weinstein monofilament test battery; muscle tone, and spasticity with the modified Tardieu scale and Digital Palpation Device, which has a very high proof value; functional status with Wolf motor function test and Motor Activity Log; quality of life will be assessed by Stroke Specific Quality of Life Scale. Participants will be included in the study according to the inclusion criteria, the first evaluation of the participants will be made according to the evaluation parameters, and the participants will be randomly distributed into three groups. The first group will be treated with M-CIMT, the second group will be treated with MCIMT with TES for 4 weeks, and the third group will be the control group. A total of 45 participants will be included in the study.
Detailed Description
This study, it is aimed to investigate the effectiveness of applied modified constraint-induced movement therapy (MCIMT) with threshold electrical stimulation (TES) in addition to conventional therapy (therapeutic exercise program) in patients with stroke. MCIMT treatment applied together with TES will be performed with electric stimulation without causing discomfort in patients with stroke and at the same time, the duration of use of the affected extremity can be extended with task-oriented exercises with MCIMT treatment. In this way, the efficiency of the applied treatment program will be evaluated, and the gains obtained will be investigated and presented as a suggestion to physiotherapists working with stroke patients. Before and after the treatment program we will evaluate, the pain level of the participants measured with a visual pain scale; sensory functions with Semmes Weinstein monofilament test battery; muscle tone, and spasticity with the modified Tardieu scale and Digital Palpation Device, which has a very high proof value; functional status with Wolf motor function test and Motor Activity Log; quality of life will be assessed by Stroke Specific Quality of Life Scale. Participants will be included in the study according to the inclusion criteria, the first evaluation of the participants will be made according to the evaluation parameters, and the participants will be randomly distributed into three groups. The first group will be treated with M-CIMT, the second group will be treated with MCIMT with TES for 4 weeks, and the third group will be the control group. A total of 45 participants will be included in the study. Participants in all three groups will be included in the routine conventional physiotherapy program. MCIMT and TES treatment will be applied three days a week for a total of four weeks. Each treatment session will continue for one and a half hours. A total of two evaluations will be applied before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, Electrical stimulation, Upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Randomized
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group-1 (M-CIMT group)
Arm Type
Experimental
Arm Description
participants in this group will be trained with Modified Constraint Induced Therapy (M-CIMT) in addition to conventional therapy. M-CIMT is shorter versions of CIMT. The original CIMT devotes six or more hours for therapy and constraining of the intact arm for 90% of waking hours per day and over a period of two weeks. Researchers have observed that such a schedule of CIMT is exhaustive and possibly resulting in non-compliance. Because of this reason,s Modified shorter versions of CIMT (mCIMT) have been designed by researchers. Duration of M-CIMT interventions varies from 2 to 10 weeks and the treatment time also varies from as short as 30 minutes to three hours per day in various studies. Nevertheless both CIMT and mCIMT have shown promising success. M-CIMT emphasizes massed practice with the affected upper limb.
Arm Title
Experimental group-2 (M-CIMT+TES group)
Arm Type
Experimental
Arm Description
participants in this group will be trained with Modified Constraint Induced Therapy (M-CIMT) and threshold electrical stimulation (TES) in addition to conventional therapy. TES is based on low-intensity (<100 Hz) and long-duration current and is applied with superficial electrodes. TES provides a natural proprioception by depolarizing the sensory and motor nerves without causing any muscle contraction. TES can improve motor learning and motor performance by improving connections between sensory-motor cortical association regions in the brain.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
participants in this group will be trained with conventional therapy. Conventional therapy consists of strength training, stretching exercises and functional activity training.
Intervention Type
Other
Intervention Name(s)
Modified Constraint Induced Therapy and Threshold Electrical Stimulation
Intervention Description
M-CIMT emphasizes massed practice with the affected upper limb with restraining unaffected limb by a mitt. Threshold electrical stimulation is based on low-intensity (<100 Hz) and long-duration current and is applied with superficial electrodes.
Primary Outcome Measure Information:
Title
Range of motion (ROM) of upper extremity
Description
A universal goniometer will be used to evaluate ROM (shoulder flexion and abduction, elbow flexion and extension, wrist flexion and extension and extension of fingers). Kendall-McCreary criteria will be considered in the assessments. Measurements will be repeated three times and the average value will be used in the statistical analysis.
Time Frame
Change from baseline Range of Motion (ROM) at week 4.
Title
Pain of upper extremity
Description
Pain (pain of shoulder, elbow, wrist and fingers) will be evaulated with VAS (Visual Analog Scale). The VAS consists of a 10 cm straight line which presents a continuum of intensity and has verbal anchors at opposite ends representing 'no pain' at the bottom and 'pain as bad as it can be' at the top. The participants will be asked to mark the representing point of their pain levels. The values will be recorded in centimeters.
Time Frame
Change from baseline pain at week 4.
Title
Muscle tone and viscoelastic properties of muscle:
Description
Muscle tone will be evaluated with the Myoton®PRO Digital Palpation Device. It is an evidence-based Class 1 device that evaluates the bio-mechanical properties of soft biological tissues in a non-invasive, objective, reliable, inexpensive, quick and easy way. Myoton® PRO is used in research to evaluate superficial skeletal muscles, connective tissues such as tendons and ligaments, and other soft tissues
Time Frame
Change from baseline muscle tone at week 4.
Title
Severity of spasticity
Description
The Modified Tardieu scale will be used to assess the severity of spasticity. In this method, the severity of spasticity is evaluated at different rates determined. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion. The Stretching Velocities are as follows: V1: As slow as possible (slower than the gravity fall speed of the limb segment) V2: At the rate of gravity fall of the limb V3: As fast as possible (faster than the normal gravity fall speed of the limb).
Time Frame
Change from baseline severity of spasticity at week 4.
Title
Superficial sensory function
Description
The Semmes Weinstein monofilament test battery will be used to evaluate the superficial sense of upper extremity. Monofilaments of varying thickness between 1.65 and 6.65 are used in this test battery. The evaluator applies in order from the smallest filament to the largest filament, the test is stopped when the monofilament is detected by the evaluator. It is a reliable method used in the superficial sensory evaluation of stroke patients.
Time Frame
Change from baseline superficial sense of upper extremity at week 4.
Title
Health-Related Quality Of Life
Description
"Stroke-specific quality of life scale (SSQOL)" will be used to evaluate quality of life. SSQOL; It is a valid and reliable scale consisting of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and productivity, and a total of 49 questions. It is graded with Likert-type scoring ranging from 1 to 5.
Time Frame
Change from baseline quality of life at week 4.
Title
Functional Status
Description
Wolf Motor Function test is used to evaluate upper extremity motor functions. For 15 activities, data is collected in 2 areas, "Functional Skill" and "Performance Time". Using the "Functional Skills Scale", each activity is evaluated between 0-5 points (0= Never used the affected hand during the activity, 5= Normal movement). The average score is calculated for the Functional Skill Scale. Performance Time" is recorded in seconds (sec).
Time Frame
Change from baseline functional status at week 4.
Title
Motor activity
Description
Motor activity diary-28 (MAG-28) will be used to evaluate motor activity. The MAG-28 is a valid and reliable scale designed to examine how often and how well a person uses their affected arm outside of the treatment session. It consists of two scales that question how often the patient uses the affected side upper extremity for each activity during daily activities (turning the light switch, opening the door, etc.) (Use Frequency Scale), and if so, how well he or she can perform the activity (Movement Quality Scale). The patient scores himself between 0 and 5 (0 = I do not use my affected arm at all, 5 = I use my affected arm with the same frequency/quality as before the stroke). For the average score, the total scores of both scales are calculated separately and divided by the number of questions
Time Frame
change from baseline motor actvity at week 4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients aged between 18-80 years Having had a stroke at least 3 months and at most 24 months ago Having an active range of motion of the upper extremity which is stated below: Shoulder flexion and abduction of at least 45 degrees Starting from a 90° flexion position, at least 20° elbow extension Starting from full of wrist flexion position at least 20° wrist extension At least 10° of extension at the metacarpophalangeal and interphalangeal joints of all fingers - Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤2 according to the Modified Ashworth Scale) Exclusion Criteria: Uncontrollable arrhythmia and/or hypertension Presence of advanced sensory deficit Visual and hearing problems Presence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity >2 according to the Modified Ashworth Scale)
Facility Information:
Facility Name
Emel Mete
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients

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