Multicontextual Treatment Approach in Stroke

Stroke Clinical Trial

Official title:

The Effect of Cognitive Rehabilitation Based on Multicontextual Treatment Approach in Stroke: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06186661
• Other study ID #: 410-01-3346
• Status: Completed
• Phase: N/A
• Start date: July 4, 2011
• Est. completion date: June 13, 2014

Study information

• Verified date: December 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 13, 2014
• Est. primary completion date: August 29, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Quality of Life
• Stroke

Intervention

Other:
• neurophysiological exercise
The content of the treatment program consisted of neurophysiological exercises based on Bobath.
• 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.

Locations

Country	Name	City	State
Turkey	Florence Nightingale Hospital Stroke Center and Sisli Memorial Hospital	Istanbul	Sisli

Sponsors (3)

Lead Sponsor	Collaborator
ozden erkan	Florence Nightingale Hospital, Istanbul, Memorial Sisli Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change outcome measure: Craig HandicapAssessment and Reporting Technique-Short Form-(CHART-SF)	It has developed to determine individuals' level of disability in their social lives, is isused for various populations such as stroke, spinal cord injury, traumatic brain injury, and multiple sclerosis. The maximum score of 100 represents the level of participation of the person without a disability.	pre-treatment and 8 weeks
Secondary	Change outcome measure: Functional Independence Measure (FIM)	Consisting of 18 items, the FIM has two main sections that evaluate motor (13 items) and cognitive functions (5 items). These two main sections are also evaluated with subgroups within themselves. A high score indicates complete independence.	pre-treatment and 8 weeks