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

NCT ID: NCT06251661

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-28

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.

Conditions

Stroke; Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (GA)

20 Egyptian ischemic stroke patients receive 12 sessions of CMR and traditional physical therapy each session lasts for 40 minutes of CMR and 30 minutes of traditional physical therapy.

Group Type: ACTIVE_COMPARATOR

Cognitive multi-sensory Rehabilition

Intervention Type: OTHER

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.

selected traditional physical therapy program.

Intervention Type: OTHER

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.

Group 2 (GB)

20 Egyptian ischemic stroke patients receive 12 sessions of traditional physical therapy each session lasts for 30 minutes.

Group Type: SHAM_COMPARATOR

selected traditional physical therapy program.

Intervention Type: OTHER

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.

Interventions

Cognitive 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.

Intervention Type: OTHER

selected 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Gehad Mohamed Mohamdeen Ali Mohamed

Lecturer Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahed Salem, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Physical Therapy Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

CMR stroke

Identifier Type: -

Identifier Source: org_study_id