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

NCT06542848 | Completed

• 1 other identifier: UBeykent-7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Stroke

Outcome Measures

Primary Outcomes (4)

• Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale

  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

  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

  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

  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)

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Physiotherapy and Rehabilitation Practices OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Beykent University

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Yasemin ŞAHBAZ, PhD

  Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: May 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)