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

NCT ID: NCT05076123

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-06-10

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group-1 (M-CIMT group)

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.

Group Type: EXPERIMENTAL

Modified Constraint Induced Therapy and Threshold Electrical Stimulation

Intervention Type: OTHER

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.

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

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.

Group Type: EXPERIMENTAL

Modified Constraint Induced Therapy and Threshold Electrical Stimulation

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified Constraint Induced Therapy and Threshold Electrical Stimulation

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Emel Mete

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emel Mete

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

doctoral thesis

Identifier Type: -

Identifier Source: org_study_id