Clinical trial NCT05128461: The Effectiveness of Telerehabilitation in Stroke Patients
Official title: The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Telerehabilitation
modified-Constraint Induced Movement Therapy
Upper Extremity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as exercise group and control group
Primary purpose: TREATMENT

Brief summary: Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.

Detailed description: This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Being diagnosed with stroke for the first time by a doctor
* Having been diagnosed with stroke at least 1 month ago
* Mini-Mental Test Score more than or equal 24
* In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints
* Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28
* Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
* Absence of severe pain to affect the treatment
* 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:

* Any orthopedic, vision, hearing or perception problems that may affect the research results
* Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.

Primary outcomes:
measure: Upper extremity motor ability-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Upper extremity motor ability-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Upper extremity motor function-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Upper extremity motor function-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Activities of daily living related to the upper extremity-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Activities of daily living related to the upper extremity-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Voluntary movement and mobility-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Voluntary movement and mobility-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
Secondary outcomes:
measure: Isometric hand strength-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Isometric hand strength-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Isometric pinch strength-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Isometric pinch strength-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: manual dexterity performance-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: manual dexterity performance-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: level of independence in activities of daily living-Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: level of independence in activities of daily living-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Research Assistant
name: Fettah SAYGILI, PT, M.Sc.
role: STUDY_CHAIR
affiliation: Professor
name: Arzu Güçlü-Gündüz, PT, PhD.
role: STUDY_DIRECTOR
References: