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Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients

Primary Purpose

CVA (Cerebrovascular Accident)

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implicit motor training program
Explicit motor training program
Selected physical therapy program
Sponsored by
Ahmed Anwar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CVA (Cerebrovascular Accident)

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age is ranging between 50 to 65 years Diagnosis of a single stroke 6 months to 2 years prior to study entry confirmed by neuroimaging reports (to minimize the chance that improvements occur because of spontaneous recovery). Sufficient cognitive and language abilities to understand and follow multiple-step instructions (a score of 24 or more on the mini mental state examination). Adequate vision to track the laser beam. Muscle strength of ≥ 3/5 for all upper extremity joints on manual muscle testing. Subjects are able at least to partially move outside of synergies at the affected elbow (Brunnstrom recovery stage in the upper limb following stroke is 4 or greater) Spasticity at the paretic elbow, wrist, or fingers, defined as a score less than 2 on the modified Ashworth scale. Exclusion Criteria: Uncontrolled seizure disorders. Additional neurological impairments, for example, Parkinson disease that (severely) influence their upper limb functions. Excessive spasticity at the paretic upper limb muscles defined as a score equal or more than 2 on the modified Ashworth scale. Excessive pain in the affected UE, as measured by a score of 5 or higher on a 10-point visual analog scale. Patients with musculoskeletal disorders of upper limb joints, such as severe arthritis, fractures, or fixed deformities. Patients with cognitive, visual, or auditory impairments.

Sites / Locations

  • Egyptians Chinese UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control group A

Study group B

Study group C

Arm Description

will be treated by selected physical therapy program only for 60 minutes.

will be treated by implicit motor training program for 30 minutes, in addition to the conventional physical therapy program for the lower extremity for 30 minutes ,total duration 60 minutes.

will be treated by explicit motor training program for 30 minutes, in addition to the conventional physical therapy program for the lower extremity for 30 minutes, total duration 60 minutes.

Outcomes

Primary Outcome Measures

Upper extremity motor ability
Wolf Motor Function Test
ADL functions of the upper extremity
Arm Motor Ability Test

Secondary Outcome Measures

Shoulder joint proprioception
laser-pointer assisted angle reproduction test

Full Information

First Posted
April 27, 2023
Last Updated
April 27, 2023
Sponsor
Ahmed Anwar
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1. Study Identification

Unique Protocol Identification Number
NCT05847595
Brief Title
Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients
Official Title
Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Anticipated)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Anwar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Training methods that improve proprioception of the shoulder joint involve specific tasks targeting joint position sense, kinesthesia, or sense of force. These exercises can involve explicit or implicit motor learning. Explicit learning involves verbal knowledge of movement performance, while implicit learning involves minimal verbal knowledge and learning in a less conscious manner. The purpose of the study is to identify the efficacy and difference between implicit and explicit motor training in improving upper extremity functions in chronic stroke patients. The study will use laser pointer pattern tracking exercises and precise repositioning tasks for explicit motor training and a cognitive-motor dual-task training for implicit motor training. The laser-pointer assisted angle reproduction test, Wolf Motor Function Test and Arm Motor Ability Test will be used for evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group A
Arm Type
Sham Comparator
Arm Description
will be treated by selected physical therapy program only for 60 minutes.
Arm Title
Study group B
Arm Type
Experimental
Arm Description
will be treated by implicit motor training program for 30 minutes, in addition to the conventional physical therapy program for the lower extremity for 30 minutes ,total duration 60 minutes.
Arm Title
Study group C
Arm Type
Experimental
Arm Description
will be treated by explicit motor training program for 30 minutes, in addition to the conventional physical therapy program for the lower extremity for 30 minutes, total duration 60 minutes.
Intervention Type
Other
Intervention Name(s)
Implicit motor training program
Intervention Description
The implicit motor training aims to create a learning situation in which the learner is not (or minimally) aware of the underlying rules of the practiced motor skill. Cognitive-motor dual-task training will be used, which involves practicing hand-reaching and grasping in different locations in space while performing cognitive tasks associated with attention, memory, and executive function. The cognitive tasks include naming words, counting backwards, counting tones, counting days and months backwards, listening to a number and counting backwards by twos and threes, telling daily stories, spelling words backward, continuous subtraction of 7 from 100, and the Stroop task. The training will be tailored to the participant's abilities.
Intervention Type
Other
Intervention Name(s)
Explicit motor training program
Intervention Description
The explicit motor training aims to create a learning situation in which the learner is very aware of the learning process by providing detailed explicit instructions on each exercise. The Motion Guidance Shoulder Kit will be used for this intervention, which involves four exercises: "Around the clock" in flexion and abduction, "Locate the Target" in active range of motion, "Butterfly" in tracing small and large butterfly patterns, and "Test your positional awareness" in locating circles with eyes open and closed. The kit involves a strap around the forearm with a laser to guide the movement of the arm during the exercises.
Intervention Type
Other
Intervention Name(s)
Selected physical therapy program
Intervention Description
The selected physical therapy program, which includes shoulder joint mobilization, graduated active exercises for shoulder muscles, hand weight bearing exercises, Approximation of the upper limb joints. While, the conventional physical therapy program for the lower extremity which includes gait training, strengthening exercises and balance training .
Primary Outcome Measure Information:
Title
Upper extremity motor ability
Description
Wolf Motor Function Test
Time Frame
4-weeks
Title
ADL functions of the upper extremity
Description
Arm Motor Ability Test
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Shoulder joint proprioception
Description
laser-pointer assisted angle reproduction test
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age is ranging between 50 to 65 years Diagnosis of a single stroke 6 months to 2 years prior to study entry confirmed by neuroimaging reports (to minimize the chance that improvements occur because of spontaneous recovery). Sufficient cognitive and language abilities to understand and follow multiple-step instructions (a score of 24 or more on the mini mental state examination). Adequate vision to track the laser beam. Muscle strength of ≥ 3/5 for all upper extremity joints on manual muscle testing. Subjects are able at least to partially move outside of synergies at the affected elbow (Brunnstrom recovery stage in the upper limb following stroke is 4 or greater) Spasticity at the paretic elbow, wrist, or fingers, defined as a score less than 2 on the modified Ashworth scale. Exclusion Criteria: Uncontrolled seizure disorders. Additional neurological impairments, for example, Parkinson disease that (severely) influence their upper limb functions. Excessive spasticity at the paretic upper limb muscles defined as a score equal or more than 2 on the modified Ashworth scale. Excessive pain in the affected UE, as measured by a score of 5 or higher on a 10-point visual analog scale. Patients with musculoskeletal disorders of upper limb joints, such as severe arthritis, fractures, or fixed deformities. Patients with cognitive, visual, or auditory impairments.
Facility Information:
Facility Name
Egyptians Chinese University
City
Cairo
ZIP/Postal Code
11757
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Anwar, MSc
Phone
+201009712291
Email
ahmad.anwar@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients

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