StrokeNCT05076123
Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients
A study testing Modified Constraint Induced Therapy and Threshold Electrical Stimulation in people with Stroke, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Modified Constraint Induced Therapy and Threshold Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Modified Constraint Induced Therapy and Threshold Electrical Stimulation
- Keywords
- stroke, rehabilitation, Electrical stimulation, Upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint Induced Therapy and Threshold Electrical StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group-1 (M-CIMT group) | Experimental | 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. Receives: Other: Modified Constraint Induced Therapy and Threshold Electrical Stimulation |
| Experimental group-2 (M-CIMT+TES group) | Experimental | 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. Receives: Other: Modified Constraint Induced Therapy and Threshold Electrical Stimulation |
| Control group | No intervention | participants in this group will be trained with conventional therapy. Conventional therapy consists of strength training, stretching exercises and functional activity training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Range of Motion (ROM) at week 4.
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.
Measured: Change from baseline pain at week 4.
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
Measured: Change from baseline muscle tone at week 4.
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).
Measured: Change from baseline severity of spasticity at week 4.
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.
Measured: Change from baseline superficial sense of upper extremity at week 4.
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.
Measured: Change from baseline quality of life at week 4.
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).
Measured: Change from baseline functional status at week 4.
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
Measured: change from baseline motor actvity at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start20 Sep 2021
- Primary completion6 Mar 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076123
- Sponsor's protocol ID
- doctoral thesis
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Constraint Induced Movement Therapy Combined With Threshold Electrical Stimulation in Stroke Patients
- ClinicalTrials.gov ID
- NCT05076123
- Acronym / sponsor ID
- doctoral thesis
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, Electrical stimulation, Upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental group-1 (M-CIMT group) | Experimental | Other: Modified Constraint Induced Therapy and Threshold Electrical Stimulationparticipants 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. |
| Experimental group-2 (M-CIMT+TES group) | Experimental | Other: Modified Constraint Induced Therapy and Threshold Electrical Stimulationparticipants 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. |
| Control group | No intervention | –participants in this group will be trained with conventional therapy. Conventional therapy consists of strength training, stretching exercises and functional activity training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Constraint Induced Therapy and Threshold Electrical StimulationM-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. | Other | Experimental group-1 (M-CIMT group), Experimental group-2 (M-CIMT+TES group) |
Primary outcome
Range of motion (ROM) of upper extremity
Time frame: Change from baseline Range of Motion (ROM) at week 4.
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
Time frame: Change from baseline pain at week 4.
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:
Time frame: Change from baseline muscle tone at week 4.
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
Time frame: Change from baseline severity of spasticity at week 4.
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
Time frame: Change from baseline superficial sense of upper extremity at week 4.
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
Time frame: Change from baseline quality of life at week 4.
"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
Time frame: Change from baseline functional status at week 4.
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
Time frame: change from baseline motor actvity at week 4.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Constraint Induced Therapy and Threshold Electrical Stimulation in people with Stroke, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) of upper extremity (time frame: Change from baseline Range of Motion (ROM) at week 4.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.