NCT05847595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

April 27, 2023

Last Update Submit

March 13, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Upper extremity motor ability

    Wolf Motor Function Test

    4-weeks

  • ADL functions of the upper extremity

    Arm Motor Ability Test

    4-weeks

Secondary Outcomes (1)

  • Shoulder joint proprioception

    4-weeks

Study Arms (3)

Control group A

SHAM COMPARATOR

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

Other: Selected physical therapy program

Study group B

EXPERIMENTAL

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.

Other: Implicit motor training programOther: Selected physical therapy program

Study group C

EXPERIMENTAL

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.

Other: Explicit motor training programOther: Selected physical therapy program

Interventions

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.

Study group B

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.

Study group C

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 .

Control group AStudy group BStudy group C

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptians Chinese University

Cairo, 11757, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of physical Therapy, Egyptian Chinese University (ECU)

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

June 10, 2023

Primary Completion

March 25, 2024

Study Completion

March 25, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations