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StrokeNCT05660902

EFFECT OF EXERCISES IN PATIENTS WITH STROKE

A study testing ROM Exercises in people with Stroke and Exercise, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Exercise
What is being tested?
ROM Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2018to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • ERciyes University

    Kayseri

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Stroke, Exercise
Being tested
ROM Exercises
Keywords
Functional Independence, Stroke, ROM Exercises, Quality of Life
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ROM ExercisesOther

    Also called Intervention Group

    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.

Study groups in NCT05660902
Study groupRoleWhat they receive
Control GroupNo interventionPatients in this group continued their routine medical treatment program without any treatment.
Intervention GroupExperimentalPatients 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.
Receives: Other: ROM Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: When the first patient was included in the group.

  2. Stroke Specific Quality of Life Scale (SS-QOL)

    The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,

    Measured: İt was applied face-to-face at the end of the 2nd week

  3. Stroke Specific Quality of Life Scale (SS-QOL)

    The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,

    Measured: When called for control at the end of the 4th week

Secondary outcomes (3)

  1. 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

    Measured: When the first patient was included in the group.

  2. Functional Independence Measure (FIM)

    The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,

    Measured: İt was applied face-to-face at the end of the 2nd week

  3. Functional Independence Measure (FIM)

    The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,

    Measured: When called for control at the end of the 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start1 Jul 2018
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660902
Sponsor's protocol ID
SVHROM
Status last verified
Dec 2022
First submitted
6 Dec 2022
Last updated
21 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28882175

  • 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.

    PubMed 16749870

  • Young JA, Tolentino M. Neuroplasticity and its applications for rehabilitation. Am J Ther. 2011 Jan;18(1):70-80. doi: 10.1097/MJT.0b013e3181e0f1a4.

    PubMed 21192249

  • 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.

    PubMed 14970894

  • 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.

    PubMed 15644146

Questions about this trial

What is this clinical trial studying?

A study testing ROM Exercises in people with Stroke and Exercise, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Specific Quality of Life Scale (SS-QOL) (time frame: When the first patient was included in the group.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660902, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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