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

NCT ID: NCT06615115

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-12-30

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.

Detailed Description

Parkinson's disease (PD) 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. Such deficits are associated with the acquisition of motor function skills. Although PD patients are open to learning, they experience challenges with motor planning. Therefore, individuals with PD may require additional training, sensory input, and motor education for the permanence and ease of motor skill acquisition.

The difficulties PD patients face with complex commands indicate that they can learn in a feedforward manner, but they show inconsistencies in the use of automatic functions. This inconsistency results in challenges in adapting to variable situations and performing complex activities (like balance and walking). Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increasing their quality of life. Recently, various additional methods have been developed to enhance the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. One commonly used method to address deficits in motor behavior is motor learning activities, which involve repetitive movements and ensure continuity.

Many studies have shown that the concept of focus of attention contributes to the efficiency and learning of various motor functions, particularly balance. Individuals with Parkinson's are highly receptive to external stimuli, so a focus-based strategy during balance and walking training can improve these skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention facilitates motor function development, reduces postural instability, and improves dual-task walking. 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, considering the presence of freezing phenomena in Parkinson's patients. Approximately 48 individuals with Parkinson's disease without freezing phenomena will participate in an exercise program for six weeks, three days a week. Participants will be randomized into a combined focus group, an external focus group, and a control group. Assessments will be repeated at the beginning and end of the six-week exercise program.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group1: Exercises with External Attention Focus Instructions

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 )

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Grup 3: Exercises with no instructions (Control Group)

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Interventions

Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Pelin Pişirici

Assistant Professor, PT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leyla Koçak, PT

Role: PRINCIPAL_INVESTIGATOR

Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy

Pelin Pişirici, PT, PhD

Role: STUDY_DIRECTOR

Bahcesehir University, Faculty of Health Sciences

Locations

Atafiz Tıp Merkezi

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Pelin Pişirici, PT, PhD

Role: CONTACT

pelinpisirici@gmail.com

05055016076

Selen Gür Özmen, MD

Role: CONTACT

selen.gur.ozmen@bau.edu.tr

05323941011

Facility Contacts

Leyla Koçak, PT

Role: primary

leyla.kocak2803@hotmail.com

+05334029807

İsmail Muştu, PT

Role: backup

mustuismail@gmail.com

+02165759444 ext. 9444

Other Identifiers

LPar24

Identifier Type: -

Identifier Source: org_study_id