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Parkinson's DiseaseNCT03815409

Treadmill in the Rehabilitation of Parkinsonian Gait

A study testing Treadmill with partial weight unload and Traditional PT rehabilitation treatment in people with Parkinson's Disease, run by IRCCS National Neurological Institute "C. Mondino" Foundation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Treadmill with partial weight unload and Traditional PT rehabilitation treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
15 Nov 2007to 30 Nov 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: Rehabilitation of Parkinsonian Gait in Body Weight Support Combined With Treadmill: a Controlled Study

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).

Read the detailed description

Gait disorders in Parkinson Disease (PD) are due to dopaminergic nigrostriatal pathways degeneration and represent important components of the disability.

In PD, gait is characterized by a significant reduction of stride length. Inadequate flexion at the ankle and knee, reduction of heel strike, forward-flexed trunk, reduced arm swing with asymmetric stride times for lower limbs and significant stride-to-stride variability are frequently associated.

The efficacy of pharmacological treatment with Levodopa is frequently incomplete and adjuvant rehabilitation treatment is recommended. Body weight-supported treadmill training (BWSTT) represents a promising rehabilitative approach for gait impairment in PD. Effectiveness of BWSTT on gait, balance and motor function has been demonstrated in different neurological diseases, especially in stroke and spinal cord injury. In PD patients, BWSTT has been tested in small controlled studies that have suggested a clinically detectable beneficial effect. BWSTT seems also effective in improving balance in PD. In PD, many data in literature show how treadmill training, acting as a sensory cue, improves kinetic and kinematic parameters, studied with computerized gait analysis (CGA) more than physiotherapy alone.

The first report of BWSTT efficacy in gait rehabilitation of PD belongs to Miyai. Ten patients with PD were enrolled in a cross-over study and treated for 4 consecutive weeks with BWSTT (20% of unweighting for 12 minutes followed by another 12-min period of 10% of unweighting) or conventional physical therapy (CPT). The Authors showed that BWSTT was superior to CPT in improving gait disturbances and disability at the end of the rehabilitative period. More specifically BWSTT proved superior to CPT in improving UPDRS scores, gait speed and stride length. The same study group in 2002 evaluated the 6-month retention of BWSTT in PD. Twenty-four patients with PD were randomized to receive BWSTT (20% of unweighting for 10 minutes + 10% of unweighting for 10 minutes + 0% of unweighting for an additional 10-min period) or CPT 3 times/week for 4 consecutive weeks. All patients were clinically evaluated at baseline and them monthly for 6 months. In this series, gait speed significantly improved in BWSTT respect to CPT only at month 1, while the improvement in the stride length was more marked in BWSTT group with respect to CPT and persisted until month 4.

In 2008 Fisher speculated on the possible central mechanism responsible for clinical effects f BWSTT. Thirty subjects affected by PD were randomly assigned to three groups: high-intensity group (24 sessions of BWSTT), low-intensity group (24 sessions of CPT), zero-intensity group (8 weeks of education classes). Again, the high-intensity group improved the most at the end of treatment period, in particular in gait speed, step length, stride length and double support. Of note, that in this study a subgroup of patients was also tested with transcranial magnetic stimulation: in the BWSTT group Authors were able to record a lengthening of the cortical silent period, postulating that high-intensity training improved neuronal plasticity in PD, through BDNF and GABA modulation.

Ustinova published the first positive case report on the short-term gait rehabilitation efficacy of BWSTT delivered to a PD patient with a robotic device (Lokomat - Hocoma Inc., Volketswil, Switzerland). The intervention consisted in a 2-week gait training, delivered 3 times per week, with each session lasting 90 to 120 minutes.

Lo conducted a pilot study to assess the efficacy of BWSTT delivered with the Lokomat unit in reducing frequency of freezing (FOG) of gait in PD. Authors reported a 20% reduction in the average number of daily episodes of FOG and a 14% improvement in the FOG-questionnaire score.

In 2012 Picelli enrolled 41 PD patients in the first randomised controlled study aimed to compare the efficacy of BWSTT delivered with a robot-assisted gait training (RAGT - gait Trainer GT1) to CPT (not focused on gait training) in improving gait in PD. They showed how RAGT was significantly superior respect to CPT in improving the 6-minute walking test, the 10-meter walking test, stride length, single/double support ratio, Parkinson's Fatigue Scale and UPDRS score.

In the present study subjects were enrolled among consecutive PD patients hospitalized in the Neuro-Rehabilitation Unit of the IRCCS Mondino Foundation of Pavia, Italy. Thirty-six patients affected by Idiopathic PD, according to the UK Brain Bank diagnostic criteria were included. Subjects were randomly assigned to two groups: 18 PD patients were assigned to the "BWSTT group" and 18 patients to the "Control group". Before starting treatment, patients of BWSTT group performed a 20-minute single session of BWSTT in order to test feasibility and tolerability. Four of them did not tolerate BWSTT: one patient reported an increase in his pre-existing hip pain, two patients with pre-existing spondyloarthrosis complained of low back pain, one patient reported that the procedure induced anxious symptoms. These 4 patients were re-allocated to the control group, so that the final disposition of patients in the two groups was as follows: 14 patients (8 women and 6 men) in the BWSTT group and 22 patients (10 women and 12 men) in the Control group.

Patients in both groups underwent 5 daily rehabilitation sessions per week for 4 consecutive weeks. Both groups underwent daily 40-minute sessions of traditional physical therapy (PT) followed by a 20-minute session of overground gait training (Control group) or of gait training with BWSTT (BWSTT group).

The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath) and previously published (25, 26) 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). This protocol was designed in accordance with PD rehabilitation guidelines and evidences in the literature.

The sessions were conducted on a treadmill with partial weight unload. Specifically, the patient performed 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.

All patients were examined by a neurologist with expertise in Movement Disorders at the beginning of hospitalization (T0) and at the end of the neurorehabilitation period (+4 weeks, T1). The clinical assessment involved a complete neurological examination and administration of the following clinical scales, validated for the assessment of the damage/disability:

  • for the assessment of PD severity: the Unified Parkinson's Disease Rating Scale, part III (UPDRS-III);
  • for the assessment of functional independence: the Functional Independence Measure (FIM).

The instrumental assessment of gait was conducted at T0 and T1 by an experienced laboratory Technician using an Optokinetic Gait Analysis System associated to the software Myolab Clinic (ELITE, BTS Engineering Milan), composed of six infrared cameras, with a sampling rate of 100 Hz. According to the Davis protocol, twenty-one spherical reflective markers (15mm in diameter) were applied along the body. Synchronized data acquisition and data processing were performed by analyzer software (BTS, Milan, Italy). In order to perform kinematic analysis of gait, patients were instructed to walk at their preferred speed along a 10-meter walkway with the initial step on the side of disease onset. For each session, the investigators acquired at least three performances and calculated the mean. In order to obtain the best individual performance, all recordings were conducted in the ON phase. The sessions were recorded at 5-min intervals to allow complete recovery from fatigue.

Being tested
Treadmill with partial weight unload, Traditional PT rehabilitation treatment
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treadmill with partial weight unloadOther

    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.

  • Traditional PT rehabilitation treatmentOther

    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)

Study groups in NCT03815409
Study groupRoleWhat they receive
BWSTT groupExperimentalThe sessions were conducted on a treadmill with partial weight unload.
Receives: Other: Treadmill with partial weight unload
Control groupOtherThe traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).
Receives: Other: Traditional PT rehabilitation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. speed of gait

    m/s - higher values represent better outcome

    Measured: after 4-week rehabilitative program

Secondary outcomes (8)
  1. Unified Parkinson's Disease Rating Scale III (UPDRS-III)

    Motor disability of Parkinson's Disease (scale from 0 to 56). Higher values represent a worse outcome.

    Measured: after 4-week rehabilitative program

  2. Functional Independence Measure (FIM)

    Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.

    Measured: after 4-week rehabilitative program

  3. Cadence of step

    step/min - higher values represent better outcome

    Measured: after 4-week rehabilitative program

  4. stride duration

    ms - higher values represent worse outcome

    Measured: after 4-week rehabilitative program

  5. stride length

    meter - higher values represent better outcome

    Measured: after 4-week rehabilitative program

  6. stance

    percentage variation - higher values represent worse outcome

    Measured: after 4-week rehabilitative program

  7. swing

    percentage variation - higher values represent better outcome

    Measured: after 4-week rehabilitative program

  8. number of strides in 10 meters

    number - higher values represent worse outcome

    Measured: after 4-week rehabilitative program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start15 Nov 2007
  3. Primary completion30 Nov 2008
  4. Study completion30 Nov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815409
Sponsor's protocol ID
Treadmill2007
Status last verified
Jan 2019
First submitted
7 Jan 2019
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 10842411
  • Knutsson E, Lindblom U, Martensson A. Lioresal and spasticity. Acta Neurol Scand Suppl. 1972;51:449-50. No abstract available.

    PubMed 4514375
  • 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.

    PubMed 10895994
  • 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.

    PubMed 24659140
  • 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.

    PubMed 9010395
  • 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.

    PubMed 2202385
  • 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.

    PubMed 12370870
  • 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.

    PubMed 16403997
  • 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.

    PubMed 26363646
  • 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.

    PubMed 26008873
  • 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.

    PubMed 20131386
  • 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.

    PubMed 25175601
  • 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.

    PubMed 30800095

Questions about this trial

What is this clinical trial studying?

A study testing Treadmill with partial weight unload and Traditional PT rehabilitation treatment in people with Parkinson's Disease, run by IRCCS National Neurological Institute "C. Mondino" Foundation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

speed of gait (time frame: after 4-week rehabilitative program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815409, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

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