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

Completed

Phase N/A Results

Trial Description

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.

Detailed 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

Conditions

Interventions

  • Stroke Other
    Intervention Desc: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
    ARM 1: Kind: Experimental
    Label: Stroke
    Description: Stroke patients at the subacute phase
  • Healthy controls Other
    Intervention Desc: no treatment
    ARM 1: Kind: Experimental
    Label: Healthy controls
    Description: healthy age-matched voluntiers

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Cohort will be selected from Fliman Rehabilitation Geriatric Center. Healthy subjects, age and gender-matched will be served as a control group.

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper Extremity Motor Function of Fugl-Meyer Assessment, by numeral point scale. The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary surface Electromyographic Assessment of Mucle co-activation index The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Handwriting velocity assessment by ComPET analyzing system by cm/sec The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary surface Electromyography assessment of Muscle onset time in mili-seconds units. The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Electromyographic assessment of Muscle amplitude analysis normalized to the maximum voluntary contraction of the same muscle. Calculated in percentage. The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Handwriting pressure will assessed by ComPET analysis software, in gr. units. The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Handwriting on-air time will assessed by ComPET analyzing system in mili-seconds units. The outcome will be measured twice. First at the begining of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Primary Change from beginning of hospital stay to end of hospital stay of Upper Extremity Motor Function of Fugl-Meyer Assessment, by numeral point scale. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of surface Electromyographic Assessment of Muscle co-activation index, in percent from absolute co-activation as 100%. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of Handwriting velocity assessment by ComPET analyzing system by cm/sec The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of surface Electromyography assessment of Muscle onset time in mili-seconds units. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of Electromyographic assessment of Muscle amplitude analysis normalized to the maximum voluntary contraction of the same muscle. Calculated in percentage. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of Handwriting pressure that will be assessed by ComPET analysis software, in gr. units. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Change from beginning of hospital stay to end of hospital stay of Handwriting on-air time that will be assessed by ComPET analyzing system in mili-seconds units. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Primary Fugl-Meyer Assessment. T1 at the beginning of the hospital stay and folloew up at T2 one month later. No
Primary Muscle Onset Time. the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1 No
Secondary Muscle Co-activation Index. T1 at the beginning of the hospital stay and folloew up at T2 one month later. No
Secondary Handwriting Velocity T1 at the beginning of the hospital stay and follow up at T2 one month later. No
Secondary % Maximum Voluntary Contraction. The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average. No
Secondary Handwriting Pressure. T1 at the beginning of the hospital stay and folloew up at T2 one mont... No
Secondary Handwriting Off-paper Time. T1 at the beginning of the hospital stay and folloew up at T2 one mont... No

Sponsors