Clinical trial NCT05076123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
Electrical stimulation
Upper extremity
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Range of motion (ROM) of upper extremity
timeFrame: Change from baseline Range of Motion (ROM) at week 4.
measure: Pain of upper extremity
timeFrame: Change from baseline pain at week 4.
measure: Muscle tone and viscoelastic properties of muscle:
timeFrame: Change from baseline muscle tone at week 4.
measure: Severity of spasticity
timeFrame: Change from baseline severity of spasticity at week 4.
measure: Superficial sensory function
timeFrame: Change from baseline superficial sense of upper extremity at week 4.
measure: Health-Related Quality Of Life
timeFrame: Change from baseline quality of life at week 4.
measure: Functional Status
timeFrame: Change from baseline functional status at week 4.
measure: Motor activity
timeFrame: change from baseline motor actvity at week 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Emel Mete
Study officials:
References: