Trials / Completed

CompletedNCT05076123

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 48 (actual)

Sponsor: Istanbul Medeniyet University · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

Start date: 2021-09-20
Primary completion: 2023-03-06
Completion: 2023-06-10
First posted: 2021-10-13
Last updated: 2023-08-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05076123. Inclusion in this directory is not an endorsement.