NCT06445998

Brief Summary

Background: The impact of stroke at the time of diagnosis is on the attention and executive functions, which may be impaired at various post-stroke intervals. Objective: To improve Cognitive Function in Elderly Stroke Patients through Task Oriented Training. Subjects and methods: Forty Elderly stroke patients from both sexes assigned randomly into two equal groups. In Group A were allocated to task oriented training in addition to traditional physical therapy program, group B received traditional physical therapy program, three sessions/week for 3 months. Cognitive Function assessed by Reha-com device, Addenbrooke's Cognitive Examination Revised (ACE-R) test and Montreal Cognitive Assessment Scale (MoCA), measured at baseline and after 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 1, 2024

Last Update Submit

June 1, 2024

Conditions

Keywords

Task Oriented Training - Cognitive Function

Outcome Measures

Primary Outcomes (3)

  • 1- Assessment of cognitive function by Reha-com device

    The computerized Reha-Com device containing the (attention and concentration) program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix, as the assessment screen is splitted into two parts. One portion represents the matrix that involves: according to (24) levels of difficulty: 3 pictures (1 by 3 matrix), 6 pictures (2 by 3 matrix) as well as 9 pictures (3 by 3 matrix), and the other part represents the separated picture.

    3 month

  • 2- Addenbrooke's Cognitive Examination Revised (ACE-R) test

    It consists of 26 tasks, divided into five domains. It takes about 15 minutes to administer. The maximum possible score is 100, and questions are asked in the sequence stated, with scores calculated immediately based on the addition of point values for each correctly answered question (10).

    3 month

  • 3- Montreal Cognitive Assessment Scale (MoCA):

    The test is commonly used to screen for cognitive impairment. It was designed to detect mild cognitive Impairment. It takes approximately 10 minutes to complete, 30-point cognitive screening instrument. It is utilized to evaluate multiple aspects of cognition, including: short-term memory; visual-spatial skills; executive function; concentration; attention; memory for work; language; as well as time-and-place awareness. The possible range of MoCA scores is 0-30. If you scored 26 or more, you're in the normal range. Scores below 25 indicate mild cognitive impairment (MCI) in individuals who have suffered a stroke, and the score has a high sensitivity (77%) as well as specificity (83%) (11).

    3 month

Study Arms (2)

Group A (study group)

EXPERIMENTAL

consisted of twenty hemiparetic patients received task oriented training in addition to traditional physical therapy program, 3 times per week for 3 month, every session for 1 hour (30 minutes task oriented training followed by 30 minutes traditional physical therapy program).

Other: task oriented training

Group B (control group)

ACTIVE COMPARATOR

consisted of twenty hemiparetic patients received the traditional physical therapy program, 3 sessions/week for 3 month, each session for 1hour.

Other: task oriented training

Interventions

Task-oriented training program: \[For study group\] Rocker board training Wobble board training Sit to stand Walk five steps forward Upstairs and downstairs three steps

Group A (study group)Group B (control group)

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Forty right-handed hemiparetic patients from both genders aged from 60 to 70 years old.
  • They are complaining from a single ischemic stroke diagnosed by Neurologist and confirmed radiologically by MRI of the brain. Duration of illness ranged from three to twelve months. Spasticity grade (1 to 1+) based on the Modified Ashworth Scale (MAS).
  • Medically as well as psychologically stable patients. All patients had normal and stable vital signs (heart rate, blood pressure, temperature as well as respiratory rate).
  • All patients had a good educational level and the body mass index ranged from 20-30 Kg/m2.

You may not qualify if:

  • Patients with Recurrent stroke or hemiparesis due to other neurological causes rather than stroke.
  • Patients with severe cardiovascular issues that have not been adequately treated. Visual, auditory and other neurological disorders.
  • Patients receiving medications that may affect cognition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horus University

Damietta, New Damietta, 17611, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zeezy S Eraky, Lecturer

    Department of Physical Therapy for Internal Medicine and Elderly

    STUDY CHAIR
  • Haitham M. Elmasry, Lecturer

    Department of Basic Science

    STUDY CHAIR
  • Ibrahim M. Hamoda, Asst Prof

    Department of Physical Therapy for Neuromuscular Disorders and its Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
traditional physical therapy
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: task oriented training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Physical Therapy for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Horus University, New Damietta, Egypt

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 6, 2024

Study Start

May 1, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations