Clinical trial NCT06251661: Cognitive Multi-sensory Rehabilitation on Upper Limb Function and Fatigue in Stroke
Official title: Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Ischemic
Keywords: CMR
Stroke
upper limb function
fatigue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: About 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. Further, post-stroke fatigue affects up to 92% of post-stroke patients. Post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. Post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery.

Preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. Cognitive Multisensory Rehabilitation (CMR) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. Cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. Because CMR integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.

Eligibility criteria: 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).

Primary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMT-UE).
timeFrame: from baseline to four weeks after the beginning of intervention
measure: Serum levels of Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: from baseline to four weeks after the beginning of intervention
measure: Changes in hand grip strength
timeFrame: from baseline to four weeks after the beginning of intervention
measure: Fatigue Assessment Scale (FAS)
timeFrame: from baseline to four weeks after the beginning of intervention
Secondary outcomes:
measure: Box and Blocks Test (BBT)
timeFrame: from baseline to four weeks after beginning of the intervention.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Nahed Salem, professor
role: STUDY_DIRECTOR
References: