Psychometric Properties of Motor Recovery Assessment Scales for Stroke

NCT ID: NCT05973058

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-05

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Stroke is a common global health-care problem that is serious and disabling. In high-income countries, stroke is the third most common cause of death and is the main cause of acquired adult disability. The most common and widely recognised impairment caused by stroke is motor impairment, in function. Measuring motor recovery can assist the clinician in diagnosis, selection of the most appropriate therapy, and outcome measurement. To date, different functional scales measuring motor recovery have been developed and used in stroke. However, only a few are specifically designed for stroke patients. The Fugl-Meyer assessment (FMA) and The Stroke Rehabilitation Assessment of Movement(STREAM) and Rivermead Motor Assessment(RMA) are the most commonly used for measuring motor recovery in stroke patients. To be clinically useful, a scale must be scientifically sound in terms of 3 basic psychometric properties: reliability, validity, and responsiveness. The objective of this study will be to compare the three clinical motor recovery measures, The Fugl-Meyer assessment motor domain (FMA-M) and mobility subscale of The Stroke Rehabilitation Assessment of Movement (STREAM) and Rivermead Motor Assessment (RMA), in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 120 days after onset. stroke patients will be followed up prospectively with the 3 measures 30,60,90, and 120 days after stroke onset (DAS). Reliability (interrater reliability and internal consistency) and validity (concurrent validity, convergent validity, and predictive validity) of each measure will be examined. A comparison of the responsiveness of each of the 3 measures will be made on the basis of the entire group of patients. the degrees of responsiveness of the 3 balance measures will be calculated on the basis of the changes occurring between 30 to 60, 60 to90, and 90 to 120, and 30 to 120 DAS. Collected data will be analyzed by using spss 21.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Stroke is a common global health-care problem that is serious and disabling. In high-income countries, stroke is the third most common cause of death and is the main cause of acquired adult disability.Stroke rehabilitation is a combined and coordinated use of medical, social, educational, and vocational measures to retrain a person who has suffered a stroke to his/her maximal physical, psychological, social, and vocational potential, consistent with physiologic and environmental limitations . In a classic report, Twitchell described in detail the pattern of motor recovery following stroke. At onset, the upper extremity (UE) is more involved than the lower extremity (LE), and eventual motor recovery in the UE is less than in the LE. The severity of UE weakness at onset and the timing of the return of movement in the hand are important predictors of eventual motor recovery in the UE. A systematic review of 58 studies confirms the most important predictive factor for upper limb recovery following stroke is the initial severity of motor impairment or function . The prognosis for return of useful hand function is unfavorable when UE paralysis is complete at onset or grasp strength is not measurable by 4 weeks. However, as many as 9% of patients with severe UE weakness at onset may gain good recovery of hand function. As many as 70% of patients showing some motor recovery in the hand by 4 weeks make a full or good recovery.Full recovery, when it occurs, usually is complete within 3 months of onset . Although most recovery from stroke takes place in the first 3 months, and only minor additional measurable improvement occurs after the 6 months following onset, recovery may continue over a longer period of time in some patients who have significant partial return of voluntary movement (8). A variety of laboratory approaches to assess motor recovery have been proposed, but the functional scales of balance measures are most commonly applied to stroke patients in clinical settings. To date, different functional scales measuring motor recovery have been developed and used in stroke research However, only a few are specifically designed for stroke patients. The Fugl-Meyer test (FMA) and the stroke Rehabilitation assessment of movement (STREAM) and the Rivermead movement assessment (RMA) are the most commonly used for measuring motor recovery in stroke patients. As a consequence, researchers and clinicians have found that they are faced with a greater range of choices but limited information on which to base their selection. No reported studies have concurrently compared the psychometric properties of the 3 measures, the FMA,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Stroke, Motor recovery, Psychometric properties

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

The criteria for the inclusion of the subject will be;

* Age between 40-70 years
* Gender both male and female
* Ability to comprehend simple instructions (Mini-Mental State Examination with a score of \> 24.
* Patient with first time of stroke (within three months of onset)
* Unilateral hemiplegic stroke patients referred by Neuro-physician (both ischemic and hemorrhagic stroke) (12).

Exclusion Criteria

* The criteria for the exclusion of the subject will be;

* Recurrent stroke
* Pre morbid diagnosis of the other neurological diseases such as TBI or Dementia
* Neurosurgical operation prior to the current status
* No informed consent
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Uzra Batool

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah Rehabilitation center

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/lhr/0205 Uzra Batool

Identifier Type: -

Identifier Source: org_study_id