Clinical trial NCT06615115: The Effect of Different Types of Focus Instructions in Parkinson's Rehabilitation
Official title: Effects of an External and Combined Focus of Attention-Instructed Exercise Program on Postural Stability and Dual-Task Walking in Parkinson's Disease: A Randomized, Assessor-Blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Cognitive Deficit in Attention
Feedback, Psychological
Gait, Festinating
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: baseline, six weeks after the baseline
measure: Time Up and Go Dual Task
timeFrame: baseline, six weeks after the baseline
Secondary outcomes:
measure: The Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: baseline, six weeks after the baseline
Other outcomes:
measure: Likert Scale Questionnaire
timeFrame: baseline, six weeks after the baseline
Locations:
city: Istanbul
country: Turkey
facility: Atafiz Tıp Merkezi
Study officials:
affiliation: Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy
name: Leyla Koçak, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahcesehir University, Faculty of Health Sciences
name: Pelin Pişirici, PT, PhD
role: STUDY_DIRECTOR
References: