search
Back to results

EFFECT OF EXERCISES IN PATIENTS WITH STROKE

Primary Purpose

Stroke, Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ROM Exercises
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Functional Independence, Stroke, ROM Exercises, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ERciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Patients in this group continued their routine medical treatment program without any treatment.

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.

Outcomes

Primary Outcome Measures

Stroke Specific Quality of Life Scale (SS-QOL)
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.
Stroke Specific Quality of Life Scale (SS-QOL)
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,
Stroke Specific Quality of Life Scale (SS-QOL)
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,

Secondary Outcome Measures

Functional Independence Measure (FIM)
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
Functional Independence Measure (FIM)
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,
Functional Independence Measure (FIM)
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,

Full Information

First Posted
December 6, 2022
Last Updated
December 14, 2022
Sponsor
TC Erciyes University
search

1. Study Identification

Unique Protocol Identification Number
NCT05660902
Brief Title
EFFECT OF EXERCISES IN PATIENTS WITH STROKE
Official Title
THE EFFECT OF EXERCISES ON FUNCTIONAL INDEPENDENCE AND QUALITY OF LIFE IN INDIVIDUALS WITH A STROKE
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Exercise
Keywords
Functional Independence, Stroke, ROM Exercises, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this group continued their routine medical treatment program without any treatment.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ROM Exercises
Other Intervention Name(s)
Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Description
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.
Time Frame
When the first patient was included in the group.
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Description
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,
Time Frame
İt was applied face-to-face at the end of the 2nd week
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Description
The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,
Time Frame
When called for control at the end of the 4th week
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
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
Time Frame
When the first patient was included in the group.
Title
Functional Independence Measure (FIM)
Description
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,
Time Frame
İt was applied face-to-face at the end of the 2nd week
Title
Functional Independence Measure (FIM)
Description
The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,
Time Frame
When called for control at the end of the 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ERciyes University
City
Kayseri
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
28882175
Citation
Munce SEP, Perrier L, Shin S, Adhihetty C, Pitzul K, Nelson MLA, Bayley MT. Strategies to improve the quality of life of persons post-stroke: protocol of a systematic review. Syst Rev. 2017 Sep 7;6(1):184. doi: 10.1186/s13643-017-0579-3.
Results Reference
background
PubMed Identifier
16749870
Citation
Thommasen HV, Zhang W. Impact of chronic disease on quality of life in the Bella Coola Valley. Rural Remote Health. 2006 Apr-Jun;6(2):528. Epub 2006 Jun 5.
Results Reference
background
PubMed Identifier
21192249
Citation
Young JA, Tolentino M. Neuroplasticity and its applications for rehabilitation. Am J Ther. 2011 Jan;18(1):70-80. doi: 10.1097/MJT.0b013e3181e0f1a4.
Results Reference
background
PubMed Identifier
14970894
Citation
Xu BH, Yu RQ, Yu W, Xie B, Huang YX. [Effects of early rehabilitation on activities of daily living and complications in acute stroke patients]. Beijing Da Xue Xue Bao Yi Xue Ban. 2004 Feb;36(1):75-8. Chinese.
Results Reference
background
PubMed Identifier
15644146
Citation
Wee HL, Cheung YB, Li SC, Fong KY, Thumboo J. The impact of diabetes mellitus and other chronic medical conditions on health-related Quality of Life: is the whole greater than the sum of its parts? Health Qual Life Outcomes. 2005 Jan 12;3:2. doi: 10.1186/1477-7525-3-2.
Results Reference
background

Learn more about this trial

EFFECT OF EXERCISES IN PATIENTS WITH STROKE

We'll reach out to this number within 24 hrs