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Cognitive Multi-sensory Rehabilitation on Upper Limb Function and Fatigue in Stroke

Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06251661
Enrollment
40
Registered
2024-02-09
Start date
2023-02-01
Completion date
2024-02-28
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic, Stroke

Keywords

CMR, Stroke, upper limb function, fatigue

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.

Interventions

OTHERCognitive multi-sensory Rehabilition

Kinetic awareness: Initially, only one joint will be moved at a time. Then the therapist will reposition the joint and ask the participants to report their perception of the joint position. Initially, the participants will distinguish between just two positions. If they reliably answer correctly, increase up to five points and integrate speed and dexterity in functional movements. Participants will be asked to relax and feel the movement during this training. Discrimination exercise: The therapist places a part of the participant's limb, the fingertip, on an external object (a block) and the participant will be asked to actively move his or her limb over the object and try to sense the shape of the object. If the participants differentiate between the two objects, then increase the number of objects (up to five). Functional training: The patient reaches toward many objects functionally (cup, ball, cane) from different angles, holds them, and relocates them again.

OTHERselected traditional physical therapy program.

The selected physical therapy program session will be occupational therapy training for the hand, strengthening exercises for the weak upper limb stretching exercises for short upper limb muscles, balance exercise, and gait training.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Assessment Scale (FAS)from baseline to four weeks after the beginning of interventiondetermine 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.
Fugl-Meyer Assessment for upper extremity (FMT-UE).from baseline to four weeks after the beginning of interventionChanges in upper limb function.
Serum levels of Brain-Derived Neurotrophic Factor (BDNF)from baseline to four weeks after the beginning of interventionChanges in serum levels of neural plasticity factors
Changes in hand grip strengthfrom baseline to four weeks after the beginning of interventionHand grip strength was measured by an electronic hand dynamometer device.

Secondary

MeasureTime frameDescription
Box and Blocks Test (BBT)from baseline to four weeks after beginning of the intervention.Changes in gross hand function intervention.

Countries

Egypt

Contacts

STUDY_DIRECTORNahed Salem, professor

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026