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Clinical Trials/NCT05133219
NCT05133219
Completed
Not Applicable

The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living in Patients With Chronic Stroke

Kocaeli University1 site in 1 country30 target enrollmentMay 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Kocaeli University
Enrollment
30
Locations
1
Primary Endpoint
Canadian Occupational Performance Measure (COPM)- Satisfaction
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.

The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.

Detailed Description

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients. The aim of the study; The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities. Thirty patients with chronic stroke will be randomized 1:1 to study (n:15) and control (n=12). Thumb localization test, finger swipe test, stereognosis test, and two-point discrimination test will be used to evaluate the sensory functions of individuals. Demographic information of individuals will be recorded with a sociodemographic information form. Before the treatment, the sensory levels of all patients will be determined by thumb localization, finger scrolling and stereognosy tests. Jebsen Taylor Hand Function Test (JTHFT), Modified Frenchay Scale (MFS), Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS) and Stroke-Specific Quality of Life Scale (SSQOL) will be administered before and after treatment.

Registry
clinicaltrials.gov
Start Date
May 23, 2022
End Date
September 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammed Rohat YAZICI

Researcher Assistant

Kocaeli University

Eligibility Criteria

Inclusion Criteria

  • Stroke duration more than 6 months,
  • To be able to communicate
  • 10 degrees of wrist dorsiflexion starting from full palmar flexion of the wrist
  • To initiate finger extension

Exclusion Criteria

  • Joint contracture in the upper and lower extremities that will affect functionality other than stroke,
  • Having a significant uncontrolled health problem and a history of epileptic seizures,
  • Having 3 or more spasticity according to the Modified Ashworth Scale (MAS),
  • Unable to communicate and cooperate,
  • With marked ataxia and dystonia,
  • Lack of movement and function in the wrist and fingers
  • Having a diagnosis of bilateral stroke

Outcomes

Primary Outcomes

Canadian Occupational Performance Measure (COPM)- Satisfaction

Time Frame: 3 weeks

Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 3.

Canadian Occupational Performance Measure (COPM)- Performance

Time Frame: 3 weeks

Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 3.

The Modified Frenchay Scale (MFS)

Time Frame: 3 weeks

The Modified Frenchay Scale (MFS) measures active upper limb function in hemiparesis based on a video review of 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. We will measured intra- and inter-rater reliability of MFS in hemiparetic patients among trained raters.

Jebsen Taylor Hand Function Test (JTHFT)

Time Frame: 3 weeks

The JTHFT is a common and detailed clinical assessment for fine motor skills with weighted and non-weighted hand functions. The test is derived from activities of daily routine and consists of writing a standardized sentence, turning over 5 cards, picking up and replacing small objects; simulated eating using a spoon and 5 kidney beans, stacking 4 draughts pieces on a board, turning over 5 large empty tins and turning over 5 full tins.

Secondary Outcomes

  • Sensory Test- Finger Shift Test(3 weeks)
  • Sensory Test- Thumb Localization Test(3 weeks)
  • Goal Attainment Scaling (GAS)(3 weeks)
  • Sensory Test- Stereognosy Test(3 weeks)
  • The Stroke Specific Quality Of Life Scale (SSQOL)(3 weeks)

Study Sites (1)

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