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

NCT05133219 | Completed

• 1 other identifier: KOU-MRYAZİCİ-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Sensory Defect

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• The Stroke Specific Quality Of Life Scale (SSQOL)

  3 weeks

• Sensory Test- Stereognosy Test

  3 weeks

• Sensory Test- Finger Shift Test

  3 weeks

• Sensory Test- Thumb Localization Test

  3 weeks

• Goal Attainment Scaling (GAS)

  3 weeks

Study Arms (2)

Research Group

EXPERIMENTAL

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

Other: Occupational Therapy

Control Group

EXPERIMENTAL

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

Other: Occupational Therapy

Interventions

Occupational Therapy OTHER

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.

Also known as: Activities of Daily Living Training, İntensified Sensory Therapy

Control Group; Research Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli Üniversitesi

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Çiğdem ÇEKMECE, PhD

  Kocaeli University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Assistant

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 24, 2021
• Study Start: May 23, 2022
• Primary Completion: August 8, 2022
• Study Completion: September 2, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)