The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05490628
Collaborator
(none)
24
2
3

Study Details

Study Description

Brief Summary

One of the most common complications in stroke patients is cognitive impairment. Cognitive impairment affects a large part of the life of stroke patients. However, the relationship between cognitive impairment and fear of falling in stroke patients has not been investigated in any study yet. Various treatment approaches have been developed to improve cognitive function. While some of these approaches focus on improving cognitive function, others aim to reach the maximum functional level with various compensation methods taught to the patient in the current cognitive situation. As a result of cognitive interventions, stroke patients' participation in daily life, adherence to treatment and quality of life increase. The aim of this study is to investigate the effects of cognitive interventions on motor performance, balance and fear of falling. This study will contribute to the literature by investigating these effects of cognitive rehabilitation.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Rehabilitation
  • Other: Conventional Therapy
N/A

Detailed Description

Participants will be randomized into two groups as control and experimental groups. The control group will receive traditional rehabilitation intervention, while the experimental group will receive additional cognitive intervention to traditional rehabilitation. Two groups will be evaluated before and after the study. Participants' motor performance, balance and fear of falling will be determined by evaluation criteria.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly divided into intervention and control groups. Both groups will be treated for 6 weeks. Each participant will be treated for a total of thirty hours, one hour a day, five days a week.Participants will be randomly divided into intervention and control groups. Both groups will be treated for 6 weeks. Each participant will be treated for a total of thirty hours, one hour a day, five days a week.
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

Traditional exercises: stretching exercises, strengthening exercises, balance exercises, walking exercises and fine motor skill exercises.

Other: Conventional Therapy
Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.

Experimental: Cognitive Rehabilitation Group

Cognitive rehabilitation; memory, executive function, attention, concentration and calculation exercises.

Other: Cognitive Rehabilitation
Language, memory, attention and executive function exercises are performed for the participants' deficient cognitive functions.

Other: Conventional Therapy
Strengthening, walking, balance and coordination exercises are performed according to the needs of the participants.

Outcome Measures

Primary Outcome Measures

  1. Montreal Cognitive Assessment [a day before the study start]

    Developed to evaluate mild cognitive impairments, Montreal Cognitive Assessment assesses different cognitive abilities including executive functions, visuospatial skills, memory, language, attention concentration, abstract thinking, calculation and orientation. It takes about 10 minutes to administer and the highest total score that can be obtained from the test is 30. Accordingly, scores of 21 and above are considered normal.

  2. Montreal Cognitive Assessment [through study completion, an average of 2 months]

    Developed to evaluate mild cognitive impairments, Montreal Cognitive Assessment assesses different cognitive abilities including executive functions, visuospatial skills, memory, language, attention concentration, abstract thinking, calculation and orientation. It takes about 10 minutes to administer and the highest total score that can be obtained from the test is 30. Accordingly, scores of 21 and above are considered normal.

  3. Fugl-Meyer Assessment [a day before the study start]

    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

  4. Fugl-Meyer Assessment [through study completion, an average of 2 months]

    The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

  5. Tinetti Balance & Gait Test [a day before the study start]

    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

  6. Tinetti Balance & Gait Test [through study completion, an average of 2 months]

    Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

  7. Falls Efficacy Scale International (FES-I) [a day before the study start]

    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.

  8. Falls Efficacy Scale International (FES-I) [through study completion, an average of 2 months]

    FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.

Secondary Outcome Measures

  1. The Timed Up & Go (TUG) Test [a day before the study start]

    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.

  2. The Timed Up & Go (TUG) Test [through study completion, an average of 2 months]

    TUG is a practical clinical assessment tool developed to measure the physical mobility and motor performance of elderly individuals. TUG measures the time for the person to stand up from the chair, walk 3 meters, and return to the chair and sit.

  3. 10 meter walking test [a day before the study start]

    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.

  4. 10 meter walking test [through study completion, an average of 2 months]

    10-meter walking test is a practical clinical assessment tool developed to measure walking capacity and motor performance of elderly individuals. The 10-meter walking test is performed by measuring the time it takes for a person to walk at normal walking speed between two markers that are 10 meters apart.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Having been diagnosed with stroke

  • The duration of the disease is in the range of 1-24 months

  • Having a score of 21 or lower on the mini mental state test

  • Having received 3 or more according to the Functional Ambulation Scale

  • Not having a vision problem that will affect the vision of the materials to be used during the treatment

  • Being able to communicate sufficiently to understand the simple orders given

Exclusion Criteria:
  • Having been diagnosed with bilateral stroke

  • Having a neurological disease other than the diagnosis of stroke

  • Development of aphasia after stroke

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

  • Study Director: Rüstem Mustafaoğlu, IstanbulUniversity-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rüstem Mustafaoğlu, Associate Professor, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05490628
Other Study ID Numbers:
  • IstanbulUC-omerfarukakan-001
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022