Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)

Study Overview
=================
Brief Summary
-----------------
We hypothesized that rehabilitation specifically addressing balance in Parkinson ́s disease patients might improve not only balance, but locomotion as well. Two balance training protocols (standing on a moving platform, and traditional balance exercises) were compared by assigning patients to two groups: moving platform (n=15) and balance exercises (n=17). Platform moved periodically in antero-posterior, latero-lateral and oblique direction, with and without vision in different trials. Balance exercises were based on Otago Exercise Program. Both platform and exercises sessions were administered from easy to difficult. Outcome measures were: a) balancing behaviour, assessed both by index of stability (IS) on platform and by Mini-BESTest, b) gait, assessed both by baropodometry and by Timed Up and Go (TUG) test. Falls Efficacy Scale-International (FES-I) and Parkinson's Disease Questionnaire (PDQ-8) were administered. Both groups exhibited better balance control, as assessed both by IS and by Mini-BESTest. Gait speed at both baropodometry and TUG also improved in both groups. Scores of FES-I and PDQ-8 showed a marginal improvement. A four-week treatment featuring no gait training, but focussed on challenging balance tasks produces considerable gait enhancement in mildly to moderately affected patients. Walking problems in PD depend on postural instability and are successfully relieved by appropriate balance rehabilitation.

Detailed Description
-----------------
The importance for training balance in connection with rehabilitation aimed at improving gait is easily stressed by considering the complex motor behaviour underpinning more challenging conditions than linear walking, as walking-and-turning, where the turn-related changes in feet, trunk and head movements are integral part of he kinematics of the steering body (Courtine and M. Schieppati, 2003; Crenna et al, 2007). It is no wonder that freezing of gait and increased risk of falling (Schlenstedt et al., 2016) is associated with abnormal bilateral coordination and turning. Hence, the present investigation somehow diverges from the theory of the task-specific training (Bayona et al., 2005), but considers instead the relevance for locomotion enhancement of training balance control, by hypothesising that specific balance rehabilitation might be sufficient for gait improvement. Here, we trained PD patients with two different treatments, both specifically addressing balance. A platform onto which subjects stood moved in antero-posterior, latero-lateral and diagonal direction in the horizontal plane. A simpler moving-platform protocol had been previously exploited for testing and enhancing balance capacities in patients with PD and with vestibular deficit (Nardone et al., 2010; De Nunzio 2007). This platform protocol challenges both the anticipatory and the reactive capacities to the ongoing postural perturbations, thereby training dynamic balance control, aiming at the balance problems encountered during every day activity. The outcome of the platform treatment was compared to that obtained in another group of matched patients with PD by standardized and validated exercises aimed at training balance and dynamic balance (Renfro et al., 2016). Of note, these exercises contained no dynamic component (i.e. gait-related exercises) of balance training, contrary to Conradsson et al. 2017. Both treatments (platform and exercises) were tailored to the patient individual capacities, and their difficulty gradually increased all along the duration of the treatment (Conradsson et al., 2017). In this context, we estimated any improvement in balance control by indexes of dynamic stability during a balance perturbation test on the mobile platform and by clinical scores related to dynamic balance control. Gait improvement was both evaluated instrumentally and assessed by a functional clinical test.

Official Title
-----------------
Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.

Conditions
-----------------
Parkinson's Disease, Rehabilitation

Intervention / Treatment
-----------------
* Other: Balance exercise
* Other: Mobile platform exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with mild to moderate idiopathic Parkinson's disease (PD) (Hoehn-Yahr stage between 1.5 and 3) Exclusion Criteria: orthopaedic conditions restricting exercise, or deep brain stimulation surgery or evidence of dementia . Patients not able walk independently.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balance exercise group<br>Each of the ten sessions was composed of 45 minutes of balance exercises, each treatment being followed by a 15-min final phase of lower limb stretching, performed with the assistance of a physiotherapist. Sessions were repeated two or three times a week, with at least one rest day between one session and the next, over four successive weeks. Each patient was treated on-phase, at the same time of the day across sessions. | Other: Balance exercise<br>* Patients in the balance exercise group received a personalized exercise program developed by an expert physiotherapist. There was no predefined duration for each item of the set of exercises, but all patients underwent an overall 45 min period training per day according to the same schedule. This schedule was based on the Otago Exercise Program and Practice Guidelines for the treatment of Parkinson's disease. Patients did not wear shoes for balance training. All exercises were performed without upper-limb support and with the supervision of a physiotherapist.<br>|
| Experimental: Mobile platform exercise group<br>Each of the ten sessions was composed of 45 minutes mobile platform training, each treatment being followed by a 15-min final phase of lower limb stretching, performed with the assistance of a physiotherapist. Sessions were repeated two or three times a week, with at least one rest day between one session and the next, over four successive weeks. Each patient was treated on-phase, at the same time of the day across sessions. | Other: Mobile platform exercise<br>* Patients entered the mobile platform and put on a security harness (no weight unloading), which they wore during the entire session on the platform training. The arms were free to move, but they were asked not to reach out for support. Each patient underwent 45 minutes of training (resting periods included), in which from 6 to 8 perturbation patterns were administered, each one lasting about 4 minutes. During training, the platform moved in the antero-posterior, latero-lateral and diagonal (45 deg) direction with respect to the body. The periodic platform displacement was 10 cm, regardless of the frequency, which could range from 0.3 to 0.6 Hz. Patients stood with eyes open and closed and feet together or 20 cm apart depending on the perturbation subtype.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of balancing behaviour by sinusoidal translation of the supporting platform. | The subjects stood upright on a platform that moved continuously 10 cm forward and backward on the horizontal plane at a frequency of sinusoidal translation of 0.4 Hz. The entire test comprised 60 cycles of motion, lasting 2 and a half min. All subjects were blindfolded, their sagittal axis co-planar with the direction of platform movement. Subjects wore a security harness and listened to music through noise-reducing earphones to mask the faint sound produced by the platform mechanism. A physiotherapist stood by the side to support the patient in case of balance loss. Body movements were recorded by detection of 3 reflective markers placed on pterion (head), greater trochanter (hip), and lateral malleolus (invariable with respect to the moving platform). The instantaneous markers' position was recorded by means of a stereometric device (Vicon 460, Oxford Metrics, UK) at a sampling frequency of 120 Hz. | 4 weeks | 
| The Mini-Balance Evaluation Systems Test | The Mini-Balance 265 Evaluation Systems Test (Mini-BESTest) is a 14-item balance scale that takes 15 min to administer. It specifically addresses dynamic equilibrium, and is highly reliable. Each item is scored on a 3-level ordinal scale from 0 to 2, with 2 representing no impairment and 0 representing severe impairment of balance. The total score ranges from 0 to 28 | 4 weeks | 
| Assessment of gait performance by baropodometry | An electronic walkway (GAITRite®, CIR Systems, Sparta, NJ, USA) returned the baropodometric gait variables. The walkway is 460 cm long, has an area of pressure sensors of 366 cm x 61 cm containing 13824 active sensors, and has a sampling frequency of 80 Hz. The GAITRite system has validity and test-retest reliability in patients with PD. Patients were instructed to walk at their usual velocity. They began walking 2 m before the walkway and continued for 2 m past the end, in order to eliminate acceleration and deceleration events from the acquisition. After one familiarizing trial, the data from four successive trials were recorded. Gait speed, step length and cadence were averaged over the four trials | 4 weeks | 
| Timed Up and Go Test (TUG) | To evaluate gait in a functional situation of daily living, we used the TUG test. This is a functional measure in which subjects stand up from a chair, walk past a horizontal line marked with tape on the floor at 3 m from start, turn around, walk back and sit down at their comfortable pace . TUG duration greater than 16 s indicates an increased risk of falls in patients with PD. The test has demonstrated an excellent test-retest and inter-rater reliability in PD. Three trials were performed, timed with a stopwatch, and the results obtained from the last two trials were averaged | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Falling | In order to evaluate fear of falling, all patients filled the Falls Efficacy Scale-International (FES-I). It is a self-report questionnaire developed for use in elderly populations to assess fear of falling. A series of 16 questions assesses the respondent's fear of falling for a range of ADLs. Each question was rated on a four-point scale from 1 ('not at all concerned' about falls) to 4 ('very concerned'). | 4 weeks | 
| The Parkinson's Disease Questionnaire (PDQ-8) | The Parkinson's Disease Questionnaire (PDQ-8) is an 8-item self-report questionnaire derived from its parent questionnaire, the PDQ-39. It exhibits appropriate levels of reliability, validity and responsiveness. Each item was rated using a five-point scale, corresponding to the frequency with which symptoms occur (from 'never ́ to 'always ́). Total score ranges from 0 to 32. A higher total score reflects a lower health-related quality of life. All patients filled both subjective questionnaires with the aid of a physiotherapist blinded regarding the allocation of the patients. | 4 weeks |