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The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living

Primary Purpose

Stroke, Sensory Defect

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occupational Therapy
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Research Group

Control Group

Arm Description

Participants will be received Intensified sensory therapy. Other: Occupational Therapy Activities of Daily Living Training Intervention: Other: Occupational therapy intervention

Participants will be received Occupational Therapy. Other: Activities of Daily Living Training

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure (COPM)- Satisfaction
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
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.
Jebsen Taylor Hand Function Test (JTHFT)
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.
The Modified Frenchay Scale (MFS)
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.

Secondary Outcome Measures

The Stroke Specific Quality Of Life Scale (SSQOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with Stroke. To assess the quality of life of stroke patients, Williams et al. The Stroke Specific Quality of Life Scale (SSQOL) created by the Institute will be used. The SSQOL consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work/productivity, and a total of 49 questions; It is graded with a Likert-type scoring ranging from 1 to 5.
Sensory Test- Stereognosy Test
Patients can easily recognize when their eyes are closed; 12 objects including water bottle, glass, scissors, paper, key, pen, glove, ruler, telephone, ball, fork and spoon were evaluated according to their naming. Patients will be evaluated in 2 groups as normal recognizing 7-12 objects and decreased recognizing 7 or less objects.
Sensory Test- Finger Shift Test
By looking at the patient's ability to distinguish up and down passive movement of the proximal thumb joint while his eyes are closed; decreased and will be considered normal.
Sensory Test- Thumb Localization Test
The patient was asked to localize the affected side with his good hand while his eyes were closed; decreased and will be considered normal.
Goal Attainment Scaling (GAS)
GAS served as the primary outcome measure. Once a patient has identified a goal area, GAS goals are established using a 5-point scale, with ''0'' reflecting a score indicating the patient met his or her goal as expected; scores of +1 or +2 indicate surpassing the desired goal, and -1 or -2 indicate inadequate goal attainment. Each potential score (i.e. -2, -1, 0, +1, +2) is based on a criterion that is established collaboratively with the patient and is measurable and specific.

Full Information

First Posted
September 9, 2021
Last Updated
September 19, 2022
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT05133219
Brief Title
The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living
Official Title
The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sensory Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research Group
Arm Type
Experimental
Arm Description
Participants will be received Intensified sensory therapy. Other: Occupational Therapy Activities of Daily Living Training Intervention: Other: Occupational therapy intervention
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Participants will be received Occupational Therapy. Other: Activities of Daily Living Training
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Other Intervention Name(s)
Activities of Daily Living Training, İntensified Sensory Therapy
Intervention Description
Occupational therapy is the only profession that helps people across the lifespan to do the things they want and need to do through the therapeutic use of daily activities (occupations). Occupational therapy practitioners enable people of all ages to live life to its fullest by helping them promote health, and prevent-or live better with-injury, illness, or disability.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)- Satisfaction
Description
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.
Time Frame
3 weeks
Title
Canadian Occupational Performance Measure (COPM)- Performance
Description
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.
Time Frame
3 weeks
Title
Jebsen Taylor Hand Function Test (JTHFT)
Description
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.
Time Frame
3 weeks
Title
The Modified Frenchay Scale (MFS)
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
The Stroke Specific Quality Of Life Scale (SSQOL)
Description
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with Stroke. To assess the quality of life of stroke patients, Williams et al. The Stroke Specific Quality of Life Scale (SSQOL) created by the Institute will be used. The SSQOL consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work/productivity, and a total of 49 questions; It is graded with a Likert-type scoring ranging from 1 to 5.
Time Frame
3 weeks
Title
Sensory Test- Stereognosy Test
Description
Patients can easily recognize when their eyes are closed; 12 objects including water bottle, glass, scissors, paper, key, pen, glove, ruler, telephone, ball, fork and spoon were evaluated according to their naming. Patients will be evaluated in 2 groups as normal recognizing 7-12 objects and decreased recognizing 7 or less objects.
Time Frame
3 weeks
Title
Sensory Test- Finger Shift Test
Description
By looking at the patient's ability to distinguish up and down passive movement of the proximal thumb joint while his eyes are closed; decreased and will be considered normal.
Time Frame
3 weeks
Title
Sensory Test- Thumb Localization Test
Description
The patient was asked to localize the affected side with his good hand while his eyes were closed; decreased and will be considered normal.
Time Frame
3 weeks
Title
Goal Attainment Scaling (GAS)
Description
GAS served as the primary outcome measure. Once a patient has identified a goal area, GAS goals are established using a 5-point scale, with ''0'' reflecting a score indicating the patient met his or her goal as expected; scores of +1 or +2 indicate surpassing the desired goal, and -1 or -2 indicate inadequate goal attainment. Each potential score (i.e. -2, -1, 0, +1, +2) is based on a criterion that is established collaboratively with the patient and is measurable and specific.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çiğdem ÇEKMECE, PhD
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Study Chair
Facility Information:
Facility Name
Kocaeli Üniversitesi
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living

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