Multicontextual Treatment Approach in Stroke

NCT ID: NCT06186661

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-04
• Study Completion Date: 2014-06-13

Brief Summary

BACKGROUND: It is known that cognitive disorders affect the rehabilitation of stroke patients but which cognitive rehabilitation intervention should apply to stroke patients and what their effects are on their life is not clear yet.

OBJECTIVE: to investigate the effects of cognitive rehabilitation including combined approaches on quality of the life and social participation of stroke patients.

METHODS: 20 patients with chronic stroke were randomly divided into two groups (Group 1 and 2), each including 10. Patients in each group were treated with neurophysiological exercises 3 times a week for 8 weeks and the subjects in Group 1 received cognitive rehabilitation additionally. The cognitive rehabilitation program consisted of individualized combined approaches including multicontextual treatment and bottom-up approaches. Loeweinstein Occupational Therapy Cognitive Assessment (LOTCA), Montreal Cognitive Assessment (MoCA) to assess cognitive status, Short Form-36 (SF-36) to assess the quality of life, Functional Independence Measure (FIM) to evaluate functional independence, Canadian Occupational Performance Measure and Craig Handicap Assessment and Reporting Technique- Short Form (CHART-SF) to evaluate social participation were used.

Detailed Description

Forty-two patients who were diagnosed with a stroke by a neurologist were admitted to the Stroke Unit of Sisli Memorial Hospital from November 2011 to April 2014. Our study was conducted on 20 patients who met the inclusion criteria of the study. Informed consent was obtained from each patient before the study. The Ethics Commission of Hacettepe University Senate (application No: 410.01-3346) approved this study. Patients were randomly divided into two groups of 10 people using a random number table. The number of cases was determined to be 10 patients for each group by using the power analysis method. Power analysis was performed based on the LOTCA and MoCA scales which are expected to have the most changes after the therapy. In this small randomized controlled trial (Small RCT); while the first group (CRG) applied a neurophysiological and cognitive rehabilitation therapy consisting of individualized combined approaches including multi-contextual treatment and bottom-up approaches, the second group (CG) implemented only a neurophysiological treatment program as the control group.

The 1st group determined by randomization applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation. The 2nd Group implemented only a 1-hour neuropsychological exercise program. The treatment programs determined for both groups were carried out 3 days a week for a total of 8 weeks. Cognitive rehabilitation sessions of the 1st group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.

While determining the cognitive rehabilitation programs of the patients; the weak areas in their cognitive skills were identified by analyzing the tests conducted before the treatment. Restorative approaches consisted of the repetition of pencil-and-paper activities and computer-based exercises according to the weak cognitive skills of the patients determined by the assessments made.

While determining a specific multi-contextual treatment intervention for the patients; their roles, personalities, habits, interests, requests, living conditions, and environments were questioned, the activities determined by COPM were revised and the essential requirements of this approach tried to be ensured.

According to this approach, using multiple environments and conditions, transfer of learning, and increasing the patient's awareness were provided. Also, the usage of various strategies and associating the new knowledge with the old knowledge were emphasized

Conditions

Stroke; Cognitive Impairment; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

The Experimental group was applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation

Group Type: EXPERIMENTAL

neurophysiological exercise

Intervention Type: OTHER

The content of the treatment program consisted of neurophysiological exercises based on Bobath.

cognitive rehabilitation

Intervention Type: OTHER

Cognitive rehabilitation sessions of the experimental group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.

Control Group

The Control Group was implemented only 1-hour neuropsychological exercise program.

Group Type: ACTIVE_COMPARATOR

neurophysiological exercise

Intervention Type: OTHER

The content of the treatment program consisted of neurophysiological exercises based on Bobath.

Interventions

neurophysiological exercise

The content of the treatment program consisted of neurophysiological exercises based on Bobath.

Intervention Type: OTHER

cognitive rehabilitation

Cognitive rehabilitation sessions of the experimental group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with the first time diagnosis of stroke, between 18-80 age range, a post-stroke period of a minimum of 6 and maximum of 24 months, with 21 or less scores on the Montreal Cognitive Assessment Scale(MoCA), who gained the sitting and standing balance and who were able to communicate enough to understand simple orders were included in the study

Exclusion Criteria

• with pre-stroke dementia or Alzheimer's diagnosis, who had vision problems and developed post-stroke aphasia, were excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florence Nightingale Hospital, Istanbul

OTHER

Sponsor Role: collaborator

Memorial Sisli Hospital, Istanbul

OTHER

Sponsor Role: collaborator

ozden erkan

OTHER

Sponsor Role: lead

Responsible Party

ozden erkan

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Özden E OGUL, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Gonca BUMIN, PhD

Role: STUDY_CHAIR

Hacettepe University

Yakup KRESPİ, MD

Role: STUDY_DIRECTOR

Istınye University /Istanbul

Locations

Florence Nightingale Hospital Stroke Center and Şişli Memorial Hospital

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

410-01-3346

Identifier Type: -

Identifier Source: org_study_id