NCT03723213

Brief Summary

In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. But these are not enough for perform the activity daily living. In order to be successful in activity daily living of the patient, performance based treatment methods should also be applied. The use of Canadian Occupational Performance Measurement (COPM), which measures patients' defined problem areas in daily practice should contribute to the patient-oriented approach process.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2019

Completed
Last Updated

February 15, 2019

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 23, 2018

Last Update Submit

February 13, 2019

Conditions

Keywords

strokeoccupational therapyactivity daily living

Outcome Measures

Primary Outcomes (1)

  • canadian occupational performance measure (COPM)

    COPM has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. The COPM prompts discussion between interviewees and therapists on factors such as different areas of activity, their concerns, and problems to be resolved. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point Likert-type scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale. Accordingly, therapists focus on these main problems or tasks.

    3 weeks interval

Secondary Outcomes (5)

  • Modified Ashworth Scale (MAS)

    3 weeks interval

  • Brunnstrom's Hemiplegia Recovery Staging

    3 weeks interval

  • Mini Mental Stage Examination

    3 weeks interval

  • The Barthel Activity Daily Living Index

    3 weeks interval

  • The Frenchay Activities Index (FAI)

    3 weeks interval

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this study we will take patients depends on a article's statistics that called "Combined Cognitive-Strategy and TaskSpecific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.20, influence quantity=0.69. Between September 10, 2018 and February 11, 2019, 26 stroke patients between the ages of 18-65 who applied for rehabilitation treatment in Kocaeli University Faculty of Medicine Department of Physical Medicine and Rehabilitation will be included.

You may qualify if:

  • Being 18 between 65 years of age,
  • To be volunteer,
  • Stability of medical conditions of patients,
  • Have a sufficient communication skills,
  • There will be not severe pain that will affect the treatment
  • At least three months after cerebrovascular disease,
  • Hemiplegia depends on cerebrovascular disease
  • There will be not serious cognitive defect \[Mini Mind Test (MMT) score of 24 and above\],
  • The patients have to have Stage of Brunnstrom is III or more appropriate,
  • Modified Ashworth Scale (MAS) score has to be 2 and below
  • Independent seating balance

You may not qualify if:

  • To be an acute term stroke
  • Patient consciousness is closed,
  • Having a history of stroke before,
  • Having a history of spinal cord lesion, traumatic brain injury, other accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia) or lower motor neuron disease,
  • Having a history of tumor, convulsion,
  • An important comorbid disease, such as severe heart disease (aortic stenosis, angina, arrhythmia, pacemaker) and uncontrolled hypertension, which may prevent rehabilitation, epileptic seizure history,
  • No volunteer
  • Excessive spasticity in the affected upper extremity joints (shoulder, elbow, wrist, fingers) \[Modified Ashworth Scale (MAS) score is ≥ 3,
  • Lack of sitting balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cigdem Cekmece

Kocaeli, İzmit, 41040, Turkey (Türkiye)

RECRUITING

Cigdem Cekmece

Kocaeli, Yahya Kaptan, 41040, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • elif ozcan

    Kocaeli University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 29, 2018

Study Start

October 24, 2018

Primary Completion

February 12, 2019

Study Completion

October 11, 2019

Last Updated

February 15, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations