Clinical trial NCT05973058: Psychometric Properties of Motor Recovery Assessment Scales for Stroke
Official title: Analysis and Comparison of Psychometric Properties of Fugl-Meyer Assessmet (FMA-M), Rivermead Motor Assessment (RMA) and Stroke Rehabilitation Assessment of Movement (STREAM) in Motor Recovery Post Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke, Motor recovery, Psychometric properties
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 57
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke

Brief summary: 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: 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,

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer assessment (FMA-M) scale
timeFrame: change from Baseline motor recovery at 30 days after stroke (DAS),change from 30 DAS to 60 DAS, change from 60 to 90 DAS, and change from 90 to 120 DAS.
measure: Rivermead motor assessment (RMA) scale
timeFrame: change from Baseline motor recovery at 30 days after stroke (DAS),change from 30 DAS to 60 DAS, change from 60 to 90 DAS, and change from 90 to 120 DAS.
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: change from Baseline motor recovery at 30 days after stroke (DAS),change from 30 DAS to 60 DAS, change from 60 to 90 DAS, and change from 90 to 120 DAS.
measure: Barthel Scale/Index (BI)
timeFrame: first reading at 30, than second reading at 60, third reading 90, and lastly at120th day after stroke(For convergent validity)
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Uzra Batool
role: PRINCIPAL_INVESTIGATOR
References: