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

NCT03314597 | Completed

• 1 other identifier: Approval number # 905 CEC
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Fear of Falling

  4 weeks

• The Parkinson's Disease Questionnaire (PDQ-8)

  4 weeks

Study Arms (2)

Balance exercise group

ACTIVE COMPARATOR

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

Mobile platform exercise group

EXPERIMENTAL

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

Interventions

Balance exercise OTHER

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.

Balance exercise group

Mobile platform exercise OTHER

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.

Mobile platform exercise group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with mild to moderate idiopathic Parkinson's disease (PD) (Hoehn-Yahr stage between 1.5 and 3)

You may not qualify if:

• orthopaedic conditions restricting exercise, or deep brain stimulation surgery or evidence of dementia . Patients not able walk independently.

Sponsors & Collaborators

• University of Pavia: lead
• Fondazione Salvatore Maugeri: collaborator

Related Publications (9)

• Bayona NA, Bitensky J, Salter K, Teasell R. The role of task-specific training in rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):58-65. doi: 10.1310/BQM5-6YGB-MVJ5-WVCR.

  PMID: 16110428 BACKGROUND

• Conradsson D, Nero H, Lofgren N, Hagstromer M, Franzen E. Monitoring training activity during gait-related balance exercise in individuals with Parkinson's disease: a proof-of-concept-study. BMC Neurol. 2017 Jan 31;17(1):19. doi: 10.1186/s12883-017-0804-7.

  PMID: 28143463 BACKGROUND

• Courtine G, Schieppati M. Human walking along a curved path. I. Body trajectory, segment orientation and the effect of vision. Eur J Neurosci. 2003 Jul;18(1):177-90. doi: 10.1046/j.1460-9568.2003.02736.x.

  PMID: 12859351 BACKGROUND

• Crenna P, Carpinella I, Rabuffetti M, Calabrese E, Mazzoleni P, Nemni R, Ferrarin M. The association between impaired turning and normal straight walking in Parkinson's disease. Gait Posture. 2007 Jul;26(2):172-8. doi: 10.1016/j.gaitpost.2007.04.010. Epub 2007 May 29.

  PMID: 17532636 BACKGROUND

• De Nunzio AM, Nardone A, Schieppati M. The control of equilibrium in Parkinson's disease patients: delayed adaptation of balancing strategy to shifts in sensory set during a dynamic task. Brain Res Bull. 2007 Sep 28;74(4):258-70. doi: 10.1016/j.brainresbull.2007.06.020. Epub 2007 Jul 23.

  PMID: 17720548 BACKGROUND

• Nardone A, Godi M, Artuso A, Schieppati M. Balance rehabilitation by moving platform and exercises in patients with neuropathy or vestibular deficit. Arch Phys Med Rehabil. 2010 Dec;91(12):1869-77. doi: 10.1016/j.apmr.2010.09.011.

  PMID: 21112428 BACKGROUND

• Renfro M, Bainbridge DB, Smith ML. Validation of Evidence-Based Fall Prevention Programs for Adults with Intellectual and/or Developmental Disorders: A Modified Otago Exercise Program. Front Public Health. 2016 Dec 6;4:261. doi: 10.3389/fpubh.2016.00261. eCollection 2016.

  PMID: 27999771 BACKGROUND

• Schlenstedt C, Muthuraman M, Witt K, Weisser B, Fasano A, Deuschl G. Postural control and freezing of gait in Parkinson's disease. Parkinsonism Relat Disord. 2016 Mar;24:107-12. doi: 10.1016/j.parkreldis.2015.12.011. Epub 2015 Dec 18.

  PMID: 26762797 BACKGROUND

• Giardini M, Nardone A, Godi M, Guglielmetti S, Arcolin I, Pisano F, Schieppati M. Instrumental or Physical-Exercise Rehabilitation of Balance Improves Both Balance and Gait in Parkinson's Disease. Neural Plast. 2018 Mar 7;2018:5614242. doi: 10.1155/2018/5614242. eCollection 2018.

  PMID: 29706993 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 19, 2017
• Study Start: April 2, 2014
• Primary Completion: December 9, 2015
• Study Completion: December 22, 2015
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share