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Treadmill in the Rehabilitation of Parkinsonian Gait

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill with partial weight unload
Traditional PT rehabilitation treatment
Sponsored by
IRCCS National Neurological Institute "C. Mondino" Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    BWSTT group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    speed of gait
    m/s - higher values represent better outcome

    Secondary Outcome Measures

    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.
    Functional Independence Measure (FIM)
    Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.
    Cadence of step
    step/min - higher values represent better outcome
    stride duration
    ms - higher values represent worse outcome
    stride length
    meter - higher values represent better outcome
    stance
    percentage variation - higher values represent worse outcome
    swing
    percentage variation - higher values represent better outcome
    number of strides in 10 meters
    number - higher values represent worse outcome

    Full Information

    First Posted
    January 7, 2019
    Last Updated
    January 24, 2019
    Sponsor
    IRCCS National Neurological Institute "C. Mondino" Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03815409
    Brief Title
    Treadmill in the Rehabilitation of Parkinsonian Gait
    Official Title
    Rehabilitation of Parkinsonian Gait in Body Weight Support Combined With Treadmill: a Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2007 (Actual)
    Primary Completion Date
    November 30, 2008 (Actual)
    Study Completion Date
    November 30, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IRCCS National Neurological Institute "C. Mondino" Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BWSTT group
    Arm Type
    Experimental
    Arm Description
    The sessions were conducted on a treadmill with partial weight unload.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    The traditional PT rehabilitation treatment included passive, active and active-assisted exercises, according to the methods commonly used (Kabat, Bobath).
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill with partial weight unload
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Traditional PT rehabilitation treatment
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    speed of gait
    Description
    m/s - higher values represent better outcome
    Time Frame
    after 4-week rehabilitative program
    Secondary Outcome Measure Information:
    Title
    Unified Parkinson's Disease Rating Scale III (UPDRS-III)
    Description
    Motor disability of Parkinson's Disease (scale from 0 to 56). Higher values represent a worse outcome.
    Time Frame
    after 4-week rehabilitative program
    Title
    Functional Independence Measure (FIM)
    Description
    Independence in activity of daily living (scale from 18 to 126). Higher values represent a better outcome.
    Time Frame
    after 4-week rehabilitative program
    Title
    Cadence of step
    Description
    step/min - higher values represent better outcome
    Time Frame
    after 4-week rehabilitative program
    Title
    stride duration
    Description
    ms - higher values represent worse outcome
    Time Frame
    after 4-week rehabilitative program
    Title
    stride length
    Description
    meter - higher values represent better outcome
    Time Frame
    after 4-week rehabilitative program
    Title
    stance
    Description
    percentage variation - higher values represent worse outcome
    Time Frame
    after 4-week rehabilitative program
    Title
    swing
    Description
    percentage variation - higher values represent better outcome
    Time Frame
    after 4-week rehabilitative program
    Title
    number of strides in 10 meters
    Description
    number - higher values represent worse outcome
    Time Frame
    after 4-week rehabilitative program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: disease stage 2-3 Hoehn &Yahr in the "on" phase; stable dosage of dopaminomimetic drugs for 3 months before study enrollment Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cristina Tassorelli, Prof
    Organizational Affiliation
    IRCCS Mondino Foundation, Pavia
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10842411
    Citation
    Morris ME. Movement disorders in people with Parkinson disease: a model for physical therapy. Phys Ther. 2000 Jun;80(6):578-97.
    Results Reference
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    Results Reference
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    PubMed Identifier
    10895994
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24659140
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9010395
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2202385
    Citation
    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.
    Results Reference
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    PubMed Identifier
    12370870
    Citation
    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.
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    PubMed Identifier
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    Citation
    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.
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    Citation
    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.
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    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.
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    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.
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    Treadmill in the Rehabilitation of Parkinsonian Gait

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