Impact of Physiotherapy on Spasticity, Upper Limb Function, Daily Activities, and Kinesiophobia in Hemiplegic Patients

August 2, 2024 updated by: Yasemin Şahbaz, University of Beykent

The Effect of Physiotherapy Rehabilitation Program on Spasticity Level, Upper Extremity Functions, Activities of Daily Living, and Kinesiophobia in Hemiplegic Patients

This study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemiplegia is a neurological condition characterized by paresis and movement limitations on one side of the body due to functional loss in one hemisphere of the brain caused by a vascular event after a stroke. This study aims to evaluate the effects of a physiotherapy and rehabilitation program on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with post-stroke hemiplegia.

Participants' spasticity levels were assessed using the Modified Ashworth Scale, upper extremity functions with the Fugl-Meyer Upper Extremity Motor Assessment, activities of daily living with the Barthel Index, and kinesiophobia levels with the Tampa Scale of Kinesiophobia. The treatment program consisted of 24 sessions, with three sessions per week. Each session lasted 45 minutes and included Transcutaneous Electrical Nerve Stimulation (TENS), range of motion exercises for upper and lower extremities, balance and coordination exercises, and weight transfer exercises. Assessments were conducted before and after the treatment.

As a result of the treatment program, a significant decrease in spasticity levels was observed in joints other than the hip joint, along with significant improvements in upper extremity functions and activities of daily living, and a significant reduction in kinesiophobia levels.

Physiotherapy and rehabilitation programs have been found to be effective in reducing spasticity, improving upper extremity functions and activities of daily living, and reducing kinesiophobia in post-stroke hemiplegic patients. These findings can contribute to the development of post-stroke rehabilitation strategies. Future research should deepen these findings with larger sample groups and long-term follow-up studies.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 22-79 years of age
  • Having been diagnosed with a stroke (SVO)
  • Possessing adequate language and cognitive skills
  • Willingness to participate voluntarily
  • Not having any chronic diseases that could affect the study outcomes

Exclusion Criteria:

  • No other neurological problems affecting functionality besides hemiplegia
  • Having cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
This group consists of patients with post-stroke hemiplegia who will undergo a physiotherapy and rehabilitation program to assess its effects on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia.
Other: Physiotherapy and Rehabilitation Practices
The treatment program consisted of 3 sessions per week, each lasting 45 minutes. The rehabilitation program included 30 minutes of conventional TENS application to the wrist extensor muscles and quadriceps muscle, upper and lower extremity exercises, balance and coordination exercises, and weight transfer exercises. The upper extremity exercises consisted of range of motion exercises for the shoulder joint, while the lower extremity exercises included range of motion exercises for the hip, knee, and ankle joints. Balance exercises included forward, backward, and lateral leaning exercises, as well as weight transfer and stepping exercises in all directions. The treatment duration was planned to be a total of 24 sessions over 8 weeks. Evaluations were conducted before and after the treatment program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale
Time Frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The primary outcome measure evaluates the changes in spasticity levels. The Modified Ashworth Scale is a measurement system based on manually assessing the resistance of specific muscle groups to passive movement. This scale evaluates the resistance encountered during passive movement of the extremity, scoring it from 0 to 4. As the score increases, it indicates a higher level of spasticity.
Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Upper Extremity Motor Function with Fugl-Meyer Assessment of Upper Extremity Motor Function
Time Frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Fugl-Meyer Assessment of Upper Extremity Motor Function is a disease-specific, objective motor impairment scale designed to evaluate recovery in hemiplegic patients following a stroke. The highest possible score on this assessment is 66. An increase in the score indicates better motor skills.
Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Daily Living Activities with Barthel Index of Activities of Daily Living
Time Frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Barthel Index of Activities of Daily Living consists of 10 items related to daily activities and mobility. The highest possible total score is 100, indicating that the individual is completely independent in their physical functions. The lowest score is 0, indicating that the individual is entirely dependent.
Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Kinesiophobia with Tampa Scale for Kinesiophobia
Time Frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Tampa Scale for Kinesiophobia is a self-report measure developed to assess fear of movement. It consists of 17 items. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. The total score, obtained by summing the individual items, ranges from 17 to 68.
Baseline (pre-treatment) and 8 weeks (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Investigators

  • Principal Investigator: Yasemin ŞAHBAZ, PhD, Beykent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBeykent-7

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Physiotherapy and Rehabilitation Practices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe