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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Sensory Defect
• Intervention / Treatment: Other: Occupational Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey
    • Kocaeli Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Research Group; Participants will be received Intensified sensory therapy. Other: Occupational Therapy Activities of Daily Living Training Intervention: Other: Occupational therapy intervention	Other: Occupational Therapy; 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.; Other Names: Activities of Daily Living Training; İntensified Sensory Therapy
Experimental: Control Group; Participants will be received Occupational Therapy. Other: Activities of Daily Living Training	Other: Occupational Therapy; 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.; Other Names: Activities of Daily Living Training; İntensified Sensory Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks
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.	3 weeks
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.	3 weeks
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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks
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.	3 weeks
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.	3 weeks
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.	3 weeks
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.	3 weeks

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Study Chair: Çiğdem ÇEKMECE, PhD, Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KOU-MRYAZİCİ-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No