Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06445998 |
| Other study ID # |
HorusU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Horus University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Methods The current study was conducted to examine the influence of task oriented training on
cognitive functions in post Elderly stroke patients. All patients were diagnosed clinically
and radiologically and referred from their neurological consultants as having post stroke
cognitive impairment (PSCI). The patients were chosen, and the study was carried- out in
outpatient clinics of Faculty of physical therapy, Horus University, this study was conducted
at the period from ============== to==============.
True experimental research design study (one factorial RCT, pre-test and post-test control
group design) was utilized. One trained research assistant assessed all patients and
collected all data to reduce inter-investigator error. Patients were randomized according to
the treatment procedure into two equal groups.
Randomization method: Patients who met the study's inclusion criteria were randomized into
two groups (A and B) utilizing a secure opaque closed envelope allocation mechanism. Group A
(study group): 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). Group B (control group): consisted of twenty hemiparetic patients received
the traditional physical therapy program, 3 sessions/week for 3 month, each session for
1hour.
Blinding: All patients were assessed and referred by the same physician and physical therapy
evaluation before beginning and at the end of the treatment program. Treatment allocations
were kept secret from both the researcher and the participants.
Inclusion criteria: 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.
Exclusion criteria: 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.
Data collection and intervention Assessment methods After being informed of the study's
goals, methods, potential benefits, privacy, as well as data use, all participants signed a
written consent form. Pre-treatment and post-treatment assessments were conducted on all
patients.
Measurement procedures:
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.
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. 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).
Intervention methods Task-oriented training program: [For study group] Rocker board training
The subject was asked to control anteroposterior then mediolateral rolling movement of the
rocking board, first placing both feet then one foot, first with eyes opened then with eyes
closed, from sitting then standing position.
Wobble board training The subject was asked to try to stop the multidirectional rolling
wobble board movement, first with eyes opened then with eyes closed, from sitting then
standing position, repeat 10 times.
Sit to stand The patient was instructed to lean forward then press on heel then stand up.
Both hands should be on the thigh and push against it to stand. This progress to be performed
with opened eyes then with closed eyes firstly on a firm surface then on foam surface with
repetitions 10 times.
Walk five steps forward From standing position, the patient was asked to walk five steps
forward firstly on a firm surface, then on foam surface and repeat 10 times.
Upstairs and downstairs three steps The patient was asked to perform upstairs five steps and
downstairs with hand supported then without hand supported, repeat 10 times.
Traditional physical therapy program: [For both groups] Range of motion exercises Range of
motion exercises was performed for the foot. The patient was asked to sit in a chair, lift
the affected foot and circle in a clockwise, then a counterclockwise motion. Repeat this
cycling five and ten times in each direction.
Strengthing exercises:
Graduate active exercise was used through strengthing of ankle dorsiflexors, planterflexor,
invertors and evertors. Proprioceptive neuromuscular facilitation was also applied to
strength distal muscles in the form of repeated contraction for dorsiflexors of ankle joint
for ten minutes.
Sensory re-education:
Tactile stimulation for both superficial and deep sensation was applied. Gait Training
Walking within parallel bar with hand supported then without hand support was participated
for ten minutes. Obstacles also were used with hand support then without hand support.
