- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05847595
Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients
March 13, 2025 updated by: Ahmed Anwar
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11757
- Egyptians Chinese University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control group A
will be treated by selected physical therapy program only for 60 minutes.
|
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 .
|
|
Experimental: Study group B
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.
|
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 .
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.
|
|
Experimental: Study group C
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.
|
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 .
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper extremity motor ability
Time Frame: 4-weeks
|
Wolf Motor Function Test
|
4-weeks
|
|
ADL functions of the upper extremity
Time Frame: 4-weeks
|
Arm Motor Ability Test
|
4-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder joint proprioception
Time Frame: 4-weeks
|
laser-pointer assisted angle reproduction test
|
4-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2023
Primary Completion (Actual)
March 25, 2024
Study Completion (Actual)
March 25, 2024
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
April 27, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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