EFFECT OF EXERCISES IN PATIENTS WITH STROKE

December 14, 2022 updated by: Özlem Ceyhan, TC Erciyes University

THE EFFECT OF EXERCISES ON FUNCTIONAL INDEPENDENCE AND QUALITY OF LIFE IN INDIVIDUALS WITH A STROKE

Aim: This study was conducted as a randomized controlled experimental study to determine the effect of ROM exercises applied to individuals who had a stroke on functional independence and quality of life.

Design: This study was conducted as a randomized controlled experimental study Methods: The study was conducted with 80 individuals, 40 of whom were in the intervention group and 40 in the control group, who received inpatient treatment in the neurology service of a regional city hospital, and met the inclusion criteria. Planned ROM exercises were applied to the individuals in the intervention group 3 times a day for 2 weeks, and no application was made to the control group other than routine treatment. Data were collected by the researcher using the Questionnaire Form, Patient Information Form, Functional Independence Scale and Stroke Specific Quality of Life Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being over 18 years old,
  • Coming to the hospital within 72 hours of having a stroke,
  • A definitive diagnosis of Cerebrovascular Diseases according to the diagnostic criteria,
  • Having a hemiplegic condition,
  • Having a score of 13 or higher on the Glasgow Coma Scale,
  • Not to be involved in any special exercise program other than the service routine,
  • Having approval from the clinician about there is no harm in doing ROM exercises,
  • Agreeing to participate in the study

Exclusion Criteria:

  • People with quadriplegia/tetraplegia,
  • Those with psychiatric illnesses,
  • Those who have any extremity amputated,
  • Those who have open wounds that prevent exercise and cause bleeding,
  • Those with fractures in their body and those who had an orthopedic operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients in this group continued their routine medical treatment program without any treatment.
Experimental: Intervention Group
Patients in this group continued their routine medical treatment program without any treatment. Moreover, ROM exercises were performed by the researcher and health personnel trained by the researcher 3 times a day for 2 weeks, approximately 30 minutes.
Other: ROM Exercises
The patients were evaluated by the physician, they were put into practice when their condition was stable within the first 72 hours. In addition to their routine treatments, according to the ROM exercise protocol, which was created by taking expert opinions and reviewing the literature ROM exercises were performed by the researcher and health personnel trained by the researcher 3 times a day for 2 weeks, approximately 30 minutes. The movements were started with the upper extremity on the unaffected side and then moved to the affected upper extremity. After the exercise applied to the affected upper extremity was finished, the same exercise was applied to the intact lower extremity and the affected lower extremity. Only the resistance points were mobilized and the exercise applied in each joint was repeated at least three times without applying extra force.
Other Names:
  • Intervention Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: When the first patient was included in the group.
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy, upper extremity functioning, self-care, work/productivity, mood, social roles, family roles, vision, language, thinking, and personality traits. The items on the scale are scored according to a five-point Likert scale: 1. strongly agree, 2. partially agree, 3. undecided, 4. partially disagree, 5. strongly disagree.
When the first patient was included in the group.
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: İt was applied face-to-face at the end of the 2nd week
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,
İt was applied face-to-face at the end of the 2nd week
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: When called for control at the end of the 4th week
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,
When called for control at the end of the 4th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: When the first patient was included in the group.
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion, communication, and social cognition. In FIM, a total of 18 activities are evaluated for functional independence using a 7-point scale for each. Level 1 represents total assistance, and level 7 represents complete independence. The highest score that can be obtained in total is 126, and the lowest score is 18. There is a direct correlation between a high score and functional independence level
When the first patient was included in the group.
Functional Independence Measure (FIM)
Time Frame: İt was applied face-to-face at the end of the 2nd week
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,
İt was applied face-to-face at the end of the 2nd week
Functional Independence Measure (FIM)
Time Frame: When called for control at the end of the 4th week
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,
When called for control at the end of the 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Estimate)

December 21, 2022

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVHROM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on ROM Exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe