Multicontextual Treatment Approach in Stroke

NCT06186661 | Completed

• 1 other identifier: 410-01-3346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Impairment; Quality of Life

Keywords

social participation; occupational therapy; stroke; cognition; quality of life

Outcome Measures

Primary Outcomes (3)

• Change outcome measure: Montreal Cognitive Assessment

  It has been developed to assess mild cognitive impairments, assesses several cognitive domains; executive functions, visuo-constructional skills, memory, language, attention and concentration, conceptual thinking, calculations, and orientation

  pre-treatment and 8 weeks

• Change outcome measure: Loewenstein Occupational Therapy Cognitive Assessment

  It has been developed to assess the basic cognitive skills in individuals with a brain damage that is caused by traumatic head injuries, stroke, and brain tumors.The LOTCA scale, the validity of which has been proved by the conducted studies so far, consists of a total of 26 subtests within 6 main areas: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, and thinking operations. A high score indicates complete cognitive skills.

  pre-treatment and 8 weeks

• Change outcome measure: Canadian Occupational Performance Measure (COPM)

  The COPM is a reliable and valid semi-structured interview measurement tool. Its reliability and validity in the patient groups with stroke have been proved.A high score indicates high performance and satisfaction.

  pre-treatment and 8 weeks

Secondary Outcomes (2)

• Change outcome measure: Craig HandicapAssessment and Reporting Technique-Short Form-(CHART-SF)

  pre-treatment and 8 weeks

• Change outcome measure: Functional Independence Measure (FIM)

  pre-treatment and 8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: neurophysiological exercise; Other: cognitive rehabilitation

Control Group

ACTIVE COMPARATOR

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

Other: neurophysiological exercise

Interventions

neurophysiological exercise OTHER

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

Control Group; Experimental Group

cognitive rehabilitation 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ozden erkan: lead
• Florence Nightingale Hospital, Istanbul: collaborator
• Memorial Sisli Hospital, Istanbul: collaborator

Study Sites (1)

Florence Nightingale Hospital Stroke Center and Şişli Memorial Hospital

Istanbul, Şişli, 34360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Özden E OGUL, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Gonca BUMIN, PhD

  Hacettepe University

  STUDY CHAIR

• Yakup KRESPİ, MD

  Istınye University /Istanbul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: January 2, 2024
• Study Start: July 4, 2011
• Primary Completion: August 29, 2011
• Study Completion: June 13, 2014
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)