The Effectiveness of Telerehabilitation in Stroke Patients

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05128461
Collaborator
(none)
16
1
2
4.9
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
  • Other: Home program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups as exercise group and control groupTwo groups as exercise group and control group
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
Actual Study Start Date :
Nov 22, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise Group

The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.

Other: Exercise
M-CIMT-based telerehabilitation will be implemented.

Other: Home program
Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.

Active Comparator: Control group

The group only will be given a home exercise program.

Other: Home program
Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.

Outcome Measures

Primary Outcome Measures

  1. Upper extremity motor ability-Baseline [Assessment will be conducted before the intervention.]

    Wolf Motor Function Test

  2. Upper extremity motor ability-Post intervention [Assessment will be conducted immediately after the intervention.]

    Wolf Motor Function Test

  3. Upper extremity motor function-Baseline [Assessment will be conducted before the intervention.]

    The Fugl-Meyer Assessment of the Upper Extremity

  4. Upper extremity motor function-Post intervention [Assessment will be conducted immediately after the intervention.]

    The Fugl-Meyer Assessment of the Upper Extremity

  5. Activities of daily living related to the upper extremity-Baseline [Assessment will be conducted before the intervention.]

    Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.

  6. Activities of daily living related to the upper extremity-Post intervention [Assessment will be conducted immediately after the intervention.]

    Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.

  7. Voluntary movement and mobility-Baseline [Assessment will be conducted before the intervention.]

    Stroke Rehabilitation Assessment of Movement (STREAM)

  8. Voluntary movement and mobility-Post intervention [Assessment will be conducted immediately after the intervention.]

    Stroke Rehabilitation Assessment of Movement (STREAM)

Secondary Outcome Measures

  1. Isometric hand strength-Baseline [Assessment will be conducted before the intervention.]

    J-Tech™

  2. Isometric hand strength-Post intervention [Assessment will be conducted immediately after the intervention.]

    J-Tech™

  3. Isometric pinch strength-Baseline [Assessment will be conducted before the intervention.]

    Baseline® pinch meter

  4. Isometric pinch strength-Post intervention [Assessment will be conducted immediately after the intervention.]

    Baseline® pinch meter

  5. manual dexterity performance-Baseline [Assessment will be conducted before the intervention.]

    nine-hole peg test (9-HTP)

  6. manual dexterity performance-Post intervention [Assessment will be conducted immediately after the intervention.]

    nine-hole peg test (9-HTP)

  7. level of independence in activities of daily living-Baseline [Assessment will be conducted before the intervention.]

    Functional Independence Measure

  8. level of independence in activities of daily living-Post intervention [Assessment will be conducted immediately after the intervention.]

    Functional Independence Measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Ankara Turkey

Sponsors and Collaborators

  • Gazi University

Investigators

  • Study Chair: Fettah SAYGILI, PT, M.Sc., Research Assistant
  • Study Director: Arzu Güçlü-Gündüz, PT, PhD., Professor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Fettah Saygılı, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier:
NCT05128461
Other Study ID Numbers:
  • 1-Stroke-CIMT-Telerehab.
First Posted:
Nov 22, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fettah Saygılı, Principal Investigator, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021