Stroke Clinical Trial
Official title:
Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients
This interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. The main question is: • Does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of study group CMR and traditional physical therapy and control group traditional physical Therapy rehabilitation. CMR 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 14, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age between 45 and 65 years. - 6-18 months after ischemic stroke - living in the community (i.e., not in a long-term care home). - medically stable. - normal score in the Montreal Cognitive Assessment (MoCA: 25 to 30, maximum score = 30). - Spasticity of upper limb muscles ranged from (grade 1:2) according to the Modified Ashworth scale. Exclusion Criteria: - severe spasticity (Modified Ashworth Scale score of 4) - any medical condition that hinders full participation, - another neurological diagnosis beyond stroke including cognitive impairment, or - upper extremity pain > 4/10 on the Numeric Pain Rating Scale (maximum 10/10). |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Physical Therapy Cairo University | Cairo | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment for upper extremity (FMT-UE). | Changes in upper limb function. | from baseline to four weeks after the beginning of intervention | |
Primary | Serum levels of Brain-Derived Neurotrophic Factor (BDNF) | Changes in serum levels of neural plasticity factors | from baseline to four weeks after the beginning of intervention | |
Primary | Changes in hand grip strength | Hand grip strength was measured by an electronic hand dynamometer device. | from baseline to four weeks after the beginning of intervention | |
Primary | Fatigue Assessment Scale (FAS) | determine the degree of self-reported fatigue in daily living activities.
Each item of the FAS is answered using a fi ve-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. |
from baseline to four weeks after the beginning of intervention | |
Secondary | Box and Blocks Test (BBT) | Changes in gross hand function intervention. | from baseline to four weeks after beginning of the intervention. |
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