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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06615115
Enrollment
48
Registered
2024-09-26
Start date
2025-01-30
Completion date
2025-12-30
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERExercise

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.

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The participant will do the evaluations but no info will be given about the randomization adn groups.

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance Scalebaseline, six weeks after the baselineThis 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.
Time Up and Go Dual Taskbaseline, six weeks after the baselineThe 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.

Secondary

MeasureTime frameDescription
The Parkinson's Disease Questionnaire-39 (PDQ-39)baseline, six weeks after the baselineThe PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).

Other

MeasureTime frameDescription
Likert Scale Questionnairebaseline, six weeks after the baselineLikert scale is a measurement tool that combines multiple Likert-type questions. It is defined as the creation of two or more Likert-type questions to address a single research problem, and using the average values of these questions during the analysis phase. The aim is to determine individuals' average attitudes on these topics based on the combined values of all questions. To determine the scope of the patient's treatment, 5 questions and a high score of 10 are evaluated. The highest score is 50, indicating that the person is satisfied with the treatment; as the score decreases, satisfaction with the treatment decreases.

Countries

Turkey (Türkiye)

Contacts

Primary ContactPelin Pişirici, PT, PhD
pelinpisirici@gmail.com05055016076
Backup ContactSelen Gür Özmen, MD
selen.gur.ozmen@bau.edu.tr05323941011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026