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Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation (AssStrFunc)

C

Carmeli Eli

Status

Completed

Conditions

Stroke

Treatments

Other: Healthy controls
Other: stroke

Study type

Observational

Funder types

Other

Identifiers

NCT02092662
UHai920130001

Details and patient eligibility

About

The purpose of this study is to evaluate by objective measures the improvement in upper extremity functioning, as reflection of motor learning, in stroke patients in the sub acute phase. The investigators hypothesize that the improvements in daily functioning are partially due to compensation strategies and partially due to motor learning.

Full description

Background: Most stroke patients continue to suffer from upper extremity motor deficiencies even after prolonged and intense rehabilitation in hospital. Even though guidelines and other studies recommend to apply a rehabilitation programs as patient reception. As opposed to that there is a scarce evidence for the efficacy of the rehabilitation.

Objectives: To evaluate by objective measures the improvement in motor performance of the upper extremity of stroke patients in the sub acute period. Secondary objective is to describe the correlation between proximal and distal motor deficiencies of the upper extremity.

Hypothesis: Patients will show better hand performance at the end of hospitalization. Part of it can be attributed to the rehabilitation and part to a spontaneous recovery. Correlation will be found for proximal and distal upper extremity motor deficiencies.

Methods:

Trial began only after the IRB research approval. All treatment sessions will implemented by the physical and occupational staff of the hospital. Assessments for the measures will be carry out by a certified physical therapist which is coinvestigator. The coinvestigator collect the raw data for analysis in Excel and than in SPSS.

20 stroke patients who meet the inclusion criteria will participate in the study, after signing an informed consent.Patients will undergo the first assessment of all measures, e.g: motor abilities by Fugl-Meyer test, handwriting kinematic and kinetic measures and surface electromyography for measurement of muscle synergy.Patients will be treated by standard rehabilitation of physical and occupational therapy for a period of 3-4 weeks. Before discharge from hospital patients will undergo another assessment of all measures, in order to evaluate the progression in their upper limb motor abilities from reception. Part of the patients will be assessed again two to three weeks after discharge as follow up.

Outcome Measures: upper limb Fugl-Meyer assessment, handwriting Air-time, pressure and velocity, EMG (i.e., muscle onset, muscle amplitude, muscle co-activation ratio).

Statistical analysis: ANOVA analysis will be used to measure time effect. Correlation between measures will be measured by Pearson's correlation. Sample size (n=20) was calculated based on 5 points improvement in Fugl-Meyer test as minimal significant change with power of 0.8 and p-level under 0.05 for significance.

Key words: Stroke, Muscle synergy, Handwriting, Fugl-Meyer

Enrollment

57 patients

Sex

All

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • diagnosis of cerebral stroke with upper extremity hemiparesis
  • Ability to understand simple orders

Exclusion criteria

  • Other orthopedic pathology
  • Apraxia
  • Bilateral Paresis
  • Other neurologic pathology
  • sensory aphasia

Trial design

57 participants in 2 patient groups

Stroke
Description:
Stroke patients at the subacute phase
Treatment:
Other: stroke
Healthy controls
Description:
healthy age-matched voluntiers
Treatment:
Other: Healthy controls

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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