The Effect of Different Types of Focus Instructions in Parkinson's Rehabilitation

NCT06615115 | Recruiting

• 1 other identifier: LPar24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increases their quality of life. Recently, various additional methods have been developed to increase the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention has been shown to facilitate motor function development, reduce postural instability, and improve dual-task walking by being easier to remember. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients. This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, taking into account the presence of freezing phenomena in Parkinson's patients.

Conditions

Parkinson Disease; Cognitive Deficit in Attention; Feedback, Psychological; Gait, Festinating

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  This is a 14-item scale that measures the ability to maintain balance during dynamic tasks. It is rated on a scale of 0 to 4 points, with a maximum total score of 56. As the total score decreases, the risk of falling increases. 0 to 20 points: Indicates that the individual is dependent on a wheelchair and has a 100% risk of falling. 21 to 40 points: Suggests that the individual has a moderate risk of falling and may be able to walk with assistance. 41 to 56 points: Indicates that the individual can ambulate independently with a low risk of falling.

  baseline, six weeks after the baseline

• Time Up and Go Dual Task

  The test assesses balance, walking, and functionality during activities. The TUG-Dual Task evaluates walking abilities and attention management by asking participants to solve a simple math problem or perform another cognitive task while walking. Patients will be assessed for functionality, walking speeds, and balance evaluations. If the duration lasts more than 12 seconds, there is a risk of falling.

  baseline, six weeks after the baseline

Secondary Outcomes (1)

• The Parkinson's Disease Questionnaire-39 (PDQ-39)

  baseline, six weeks after the baseline

Other Outcomes (1)

• Likert Scale Questionnaire

  baseline, six weeks after the baseline

Study Arms (3)

Group1: Exercises with External Attention Focus Instructions

EXPERIMENTAL

Throughout the descriped exercise program, the physiotherapist will guide the participants using only external focus of attention instructions. Example: Go over the red block. (10 rounds )

Other: Exercise

Group 2: Exercises with Combined Attention Focus Instructions

EXPERIMENTAL

The exercise program given to the External Focus of Attention group will also be administered to this group. While guiding the exercises, the physiotherapist will use a combination of both external and internal focus of attention instructions to direct the participants. Example: Pass over the red block by pulling your knees up as high as you can.

Other: Exercise

Grup 3: Exercises with no instructions (Control Group)

EXPERIMENTAL

The same exercise program given to the other groups will also be administered to this group but no instruction will be given to this group. Example: Take 10 turn around the track, passing over the blocks

Other: Exercise

Interventions

Exercise OTHER

All participants will perform a total body stretching exercise for 10 minutes, followed by 10 minutes of obstacle course navigation, 10 minutes of balance training (including tandem walking, balance board exercises, single-leg balance, and two-legged reaching exercises), and will conclude with 10 minutes of strength training exercises.

Group 2: Exercises with Combined Attention Focus Instructions; Group1: Exercises with External Attention Focus Instructions; Grup 3: Exercises with no instructions (Control Group)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn and Yahr Stage II or III
• Individuals between the ages of 50 and 70 who can walk independently but have balance disorders
• Having a score between 21-56 on the Berg Balance Scale
• Having a score between 24-30 on the Mini Mental State Test
• Having agreed to participate in the study (Not having a freezing phenomenon)
• Being in the Medication-on period

You may not qualify if:

• Having malignancy and metabolic diseases
• Having had Cerebrovascular Accident before
• Other neurological disease history
• Presence of cognitive problems
• Presence of visual or hearing disorders
• Presence of deep brain pacemaker
• Presence of freezing phenomenon (persons with Freezing of Gait Questionnaire FOG-Q above zero)
• Presence of dyskinesia

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Atafiz Tıp Merkezi

Istanbul, 34636, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leyla Koçak, PT

  Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy

  PRINCIPAL INVESTIGATOR

• Pelin Pişirici, PT, PhD

  Bahcesehir University, Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Pelin Pişirici, PT, PhD

CONTACT

05055016076; pelinpisirici@gmail.com

Selen Gür Özmen, MD

CONTACT

05323941011; selen.gur.ozmen@bau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant will do the evaluations but no info will be given about the randomization adn groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PT, PhD

Model Details: Participants who meet the inclusion criteria will be randomized into external focus of attention, combined focus of attention, and control groups. The same exercise program will be administered to all three groups by the same physiotherapist. The exercise program will last for 6 weeks, with sessions held three times a week. Although the exercises will be the same, the instructions given to the patients will vary by group. Assessments will be repeated at the beginning of treatment and at the end of the 6th week by a blinded evaluator.

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: January 30, 2025
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)