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Completed

NCT Number: NCT05660902

EFFECT OF EXERCISES IN PATIENTS WITH 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ERciyes University

Kayseri, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ROM Exercises

Other

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

Primary outcomes

  1. 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.

  2. 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,

  3. 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,

Secondary outcomes

  1. 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

  2. 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,

  3. 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,

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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