Treadmill in the Rehabilitation of Parkinsonian Gait

NCT03815409 | Completed

• 1 other identifier: Treadmill2007
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gait disorders represent disabling symptoms in Parkinson's Disease (PD). The effectiveness of rehabilitation treatment with Body Weight Support Treadmill Training (BWSTT) has been demonstrated in patients with stroke and spinal cord injuries, but limited data is available in PD. The aim of the study is to investigate the efficacy of BWSTT in the rehabilitation of gait in PD patients. Thirty-six PD inpatients were enrolled and performed rehabilitation treatment for 4 weeks, with daily sessions. Subjects were randomly divided into two groups: both groups underwent daily 40-minute sessions of traditional physiokinesitherapy followed by 20-minute sessions of overground gait training (Control group) or BWSTT (BWSTT group). The efficacy of BWSTT was evaluated with clinical scales and Computerized Gait Analysis (CGA). Patients were tested at baseline (T0) and at the end of the 4-week rehabilitation period (T1).

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• speed of gait

  m/s - higher values represent better outcome

  after 4-week rehabilitative program

Secondary Outcomes (8)

• Unified Parkinson's Disease Rating Scale III (UPDRS-III)

  after 4-week rehabilitative program

• Functional Independence Measure (FIM)

  after 4-week rehabilitative program

• Cadence of step

  after 4-week rehabilitative program

• stride duration

  after 4-week rehabilitative program

• stride length

  after 4-week rehabilitative program

Study Arms (2)

BWSTT group

EXPERIMENTAL

The sessions were conducted on a treadmill with partial weight unload.

Other: Treadmill with partial weight unload

Control group

OTHER

The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).

Other: Traditional PT rehabilitation treatment

Interventions

Treadmill with partial weight unload OTHER

10-minute treadmill walk with a support corresponding to 20% of his/her own weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a support corresponding to 10% of his/her own weight. In the initial treadmill session, the starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per minute were added to reach the maximum speed that was comfortably tolerated by the patient. This latter was used for the entire training period.

BWSTT group

Traditional PT rehabilitation treatment OTHER

Every 40-minute treatment session consisted in isotonic and isometric exercises for the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5 minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for functional purposes (10 minutes), balance training exercises (10 minutes), relaxation exercises (5 minutes)

Control group

Eligibility Criteria

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

You may qualify if:

• disease stage 2-3 Hoehn \&Yahr in the "on" phase;
• stable dosage of dopaminomimetic drugs for 3 months before study enrollment

You may not qualify if:

• moderate to severe cognitive impairment (MMSE ≤ 21),
• advanced PD (Hoehn and Yahr \[H\&Y\] stage \>3),
• unpredictable motor fluctuations
• moderate to severe orthopedic problems or other pathological conditions (e.g. severe postural abnormalities) that might affect gait training.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Related Publications (13)

• Morris ME. Movement disorders in people with Parkinson disease: a model for physical therapy. Phys Ther. 2000 Jun;80(6):578-97.

  PMID: 10842411 BACKGROUND

• Knutsson E, Lindblom U, Martensson A. Lioresal and spasticity. Acta Neurol Scand Suppl. 1972;51:449-50. No abstract available.

  PMID: 4514375 BACKGROUND

• Miyai I, Fujimoto Y, Ueda Y, Yamamoto H, Nozaki S, Saito T, Kang J. Treadmill training with body weight support: its effect on Parkinson's disease. Arch Phys Med Rehabil. 2000 Jul;81(7):849-52. doi: 10.1053/apmr.2000.4439.

  PMID: 10895994 BACKGROUND

• Ganesan M, Pal PK, Gupta A, Sathyaprabha TN. Treadmill gait training improves baroreflex sensitivity in Parkinson's disease. Clin Auton Res. 2014 Jun;24(3):111-8. doi: 10.1007/s10286-014-0236-z.

  PMID: 24659140 BACKGROUND

• McIntosh GC, Brown SH, Rice RR, Thaut MH. Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):22-6. doi: 10.1136/jnnp.62.1.22.

  PMID: 9010395 BACKGROUND

• Bowes SG, Clark PK, Leeman AL, O'Neill CJ, Weller C, Nicholson PW, Deshmukh AA, Dobbs SM, Dobbs RJ. Determinants of gait in the elderly parkinsonian on maintenance levodopa/carbidopa therapy. Br J Clin Pharmacol. 1990 Jul;30(1):13-24. doi: 10.1111/j.1365-2125.1990.tb03738.x.

  PMID: 2202385 RESULT

• Miyai I, Fujimoto Y, Yamamoto H, Ueda Y, Saito T, Nozaki S, Kang J. Long-term effect of body weight-supported treadmill training in Parkinson's disease: a randomized controlled trial. Arch Phys Med Rehabil. 2002 Oct;83(10):1370-3. doi: 10.1053/apmr.2002.34603.

  PMID: 12370870 RESULT

• Toole T, Maitland CG, Warren E, Hubmann MF, Panton L. The effects of loading and unloading treadmill walking on balance, gait, fall risk, and daily function in Parkinsonism. NeuroRehabilitation. 2005;20(4):307-22.

  PMID: 16403997 RESULT

• Mehrholz J, Kugler J, Storch A, Pohl M, Hirsch K, Elsner B. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2015 Sep 13;2015(9):CD007830. doi: 10.1002/14651858.CD007830.pub4.

  PMID: 26363646 RESULT

• Ganesan M, Sathyaprabha TN, Pal PK, Gupta A. Partial Body Weight-Supported Treadmill Training in Patients With Parkinson Disease: Impact on Gait and Clinical Manifestation. Arch Phys Med Rehabil. 2015 Sep;96(9):1557-65. doi: 10.1016/j.apmr.2015.05.007. Epub 2015 May 23.

  PMID: 26008873 RESULT

• Bartolo M, Serrao M, Tassorelli C, Don R, Ranavolo A, Draicchio F, Pacchetti C, Buscone S, Perrotta A, Furnari A, Bramanti P, Padua L, Pierelli F, Sandrini G. Four-week trunk-specific rehabilitation treatment improves lateral trunk flexion in Parkinson's disease. Mov Disord. 2010 Feb 15;25(3):325-31. doi: 10.1002/mds.23007.

  PMID: 20131386 RESULT

• Tassorelli C, De Icco R, Alfonsi E, Bartolo M, Serrao M, Avenali M, De Paoli I, Conte C, Pozzi NG, Bramanti P, Nappi G, Sandrini G. Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of Pisa syndrome in Parkinson disease: a placebo controlled study. Parkinsonism Relat Disord. 2014 Nov;20(11):1140-4. doi: 10.1016/j.parkreldis.2014.07.015. Epub 2014 Aug 13.

  PMID: 25175601 RESULT

• Berra E, De Icco R, Avenali M, Dagna C, Cristina S, Pacchetti C, Fresia M, Sandrini G, Tassorelli C. Body Weight Support Combined With Treadmill in the Rehabilitation of Parkinsonian Gait: A Review of Literature and New Data From a Controlled Study. Front Neurol. 2019 Feb 8;9:1066. doi: 10.3389/fneur.2018.01066. eCollection 2018.

  PMID: 30800095 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 Officials

• Cristina Tassorelli, Prof

  IRCCS Mondino Foundation, Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 24, 2019
• Study Start: November 15, 2007
• Primary Completion: November 30, 2008
• Study Completion: November 30, 2008
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share