NCT05660902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

December 6, 2022

Last Update Submit

December 14, 2022

Conditions

StrokeExercise

Keywords

Functional IndependenceStrokeROM ExercisesQuality of Life

Outcome Measures

Primary Outcomes (3)

  • 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.

    When the first patient was included in the group.

  • Stroke Specific Quality of Life Scale (SS-QOL)

    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)

    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 Outcomes (3)

  • Functional Independence Measure (FIM)

    When the first patient was included in the group.

  • Functional Independence Measure (FIM)

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

  • Functional Independence Measure (FIM)

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

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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

Interventions

ROM ExercisesOTHER

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.

Also known as: Intervention Group
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ERciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 28882175BACKGROUND

  • 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.

    PMID: 16749870BACKGROUND

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

    PMID: 21192249BACKGROUND

  • 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.

    PMID: 14970894BACKGROUND

  • 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.

    PMID: 15644146BACKGROUND

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 21, 2022

Study Start

July 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

TU(1)