Upper Limb Movement Quality Following Stroke

Recruiting

• Conditions: Stroke

• Registration Number: NCT06497881
• Lead Sponsor: Adi Negev-Nahalat Eran

Brief Summary

The aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment.

Detailed Description

This study is part of The Natural History of Stroke Recovery project. In this study the investigators plan to develop, test and validate an algorithm and software for using Inertial Measuring Units (IMUs) to monitor upper limb daily movement. Then, investigators plan to use this system to monitor such activity in stroke patients.

Investigators also plan to develop, test and validate an algorithm and software to test proprioception acuity based on muscle synergy during active and passive movement. Muscle synergy will be determined based on muscles' electrical activity, as measured using surface electromyography (EMG).

Investigators will then test the relation between daily movements of the upper limb in stroke patients, and their recovery/impairment levels, including proprioception acuity.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study Start: 2024-07-04
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-12
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• >18 years of age
• Independent in all activities of daily living before the stroke.
• In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center.
• Medically stable
• Able to provide informed consent.

Exclusion Criteria

• The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
• Traumatic brain injury and/or extra-cerebral hemorrhage.
• Significant psychiatric condition, including alcoholism and drug abuse.
• Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Active joint range	One or two occasions over 1-6 hours each.	Maximum, minimum, and mean range of motion of the joints during daily activity. Measured in degrees/radians.
Hand movements-count	One or two occasions over 1-6 hours each.	The number of hand movements (count)
Wrist distance	One or two occasions over 1-6 hours each.	The maximum, average and total distance of the wrist from the body during movements. Measured in cm.
Hand movements-duration	One or two occasions over 1-6 hours each.	The total and average (per hour) time the hands moved, over the tested period. Measured in minutes.

Secondary Outcome Measures

Name	Time	Method
Proprioception-1	One occasions during the first month following recruitment.	The difference between joint angles in an angle matching task. E.g., matching the shoulder angle of a passively moved arm with the contralateral arm. Angles include both anatomical angles and elevation angles. Measured in degrees/radians.
Angular velocity.	One or two occasions over 1-6 hours each.	Maximum and average angular velocity of the joints during daily activity. Measured in degrees/radians per second
Action Research Arm Test (ARAT)	One occasions during the first month following recruitment.	Action Research Arm Test Score is on a 0-57 scale. High score is better.
Joint range of motion	One or two occasions over 1-6 hours each.	Maximum and minimum joints range of motion (active and passive). Measured in degrees/radians.
Synergies	One or two occasions over 1-6 hours each.	Parameters of the correlation (regression) between the kinematic signals of the different upper extremity segments. Including the slope (arbitrary units) and R\^2 (arbitrary units).
Whole body movement time	One or two occasions over 1-6 hours each.	The total and average (per hour) time of movements of the whole body. Measured in minutes.
Fugl-Meyer Assessment (FMA)	One occasions during the first month following recruitment.	Fugl-Meyer Assessment: Motor score of the upper limb is on a 0-66 scale. High score is better.
Proprioception-2	One occasions during the first month following recruitment.	Parameters of the correlation (regression) between EMG signals during active and passive movement. Including the constant (in mV), slope (arbitrary units) and R\^2 (arbitrary units).
Proprioception-3	One occasions during the first month following recruitment.	Delay between hand movement initiation observed kinematical (acceleration) and kinetically (EMG signal). Measured in msec.
Movement volume	One or two occasions over 1-6 hours each.	Volume occupied by the limb segments calculated using the 3D location of the joints. Measured in cm\^3.

Trial Locations

Locations (1)

Adi-Negev Nahalat Eran; 🇮🇱 Ofakim, Israel