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

NCT06251661 | Completed DMC

• 1 other identifier: CMR stroke
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Ischemic

Keywords

CMR; Stroke; upper limb function; fatigue

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment for upper extremity (FMT-UE).

  Changes in upper limb function.

  from baseline to four weeks after the beginning of intervention

• 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

• 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

• 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 Outcomes (1)

• Box and Blocks Test (BBT)

  from baseline to four weeks after beginning of the intervention.

Study Arms (2)

Group 1 (GA)

ACTIVE COMPARATOR

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.

Other: Cognitive multi-sensory Rehabilition; Other: selected traditional physical therapy program.

Group 2 (GB)

SHAM COMPARATOR

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

Other: selected traditional physical therapy program.

Interventions

Cognitive multi-sensory Rehabilition 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.

Group 1 (GA)

selected traditional physical therapy program. 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 1 (GA); Group 2 (GB)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: The study will be applied to ischemic stroke. This type of stroke is more common in males than females because most smokers are males. As known, smoking is the major cause of ischemic stroke due to atherosclerotic changes in cerebral blood vessels.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 45 and 65 years.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Giza Governorate, 12612, Egypt

Location

MeSH Terms

Conditions

Stroke; Ischemia; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nahed Salem, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 1, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 28, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)