Robotic Gait Training in Spinal Cord Injury

NCT02749357 | Completed DMC

• 1 other identifier: 35/15
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: The ability to move and transfer own body in an effective manner, is frequently affected in people with a spinal cord injury with a negative impact in mood and quality of life, in such a way, that achieving an effective locomotion, is one of the main objectives in the rehabilitation program in a spinal cord injured patient. There are different modalities of locomotion training in spinal cord injury, being the robotic orthosis among them, and offering until now, positive outcomes. However there´s still a lack of evidence of the optimal training characteristics, in order to establish the best time, number of sessions, and progression scheme. For these reasons, establishing the effects of different locomotion training programs will provide the necessary data in order to develop an effective training program for the maximum benefit of the patient. OBJECTIVE To determine the effect of different training programs with robotic gait orthosis for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury Association Impairment Scale (AIS) C / D) in short and long term. METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the observer, clinical trial. Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C and D, with at least 6 months of evolution, and who are able to walk with or without gait auxiliary, will be eligible. Informed consent will be obtained from all subjects prior to participation. Patients will be randomly assigned to either one of the two different training groups: intervention or control group. The control group will be submitted to training sessions of 30 minutes, and the intervention group will have training sessions of 60 minutes. Both groups will receive a training period of six weeks, five days a week. Throughout the training period, gait assessments with the GaitRite instrument, will be performed, and repeated at 6 and 12 months after completion of the training as part of follow up. The data obtained from the GaitRite will be compared within each group, in order to determine which type of training is more effective Statistical analysis will be performed using SPSS, considering all P \< 0.05 as statistically significant.

Conditions

Spinal Cord Injuries

Keywords

gait; robotic orthosis

Outcome Measures

Primary Outcomes (100)

• Baseline Gait speed

  Analysed by the Gait Rite system (m/s)

  Before training

• Change in gait speed at first training session

  Analysed by the Gait Rite system (m/s)

  Before and after the first session of training (day 1)

• Change in gait speed at second training session

  Analysed by the Gait Rite system (m/s)

  Before and after the second session of training (day 2)

• Change in gait speed at third training session

  Analysed by the Gait Rite system (m/s)

  Before and after the third session of training (day3)

• Change from baseline gait speed at first week

  Analysed by the Gait Rite system (m/s)

  At the end of the first training week

• Change from baseline gait speed at second week

  Analysed by the Gait Rite system (m/s)

  At the end of the second training week

• Change from baseline gait speed at fourth week

  Analysed by the Gait Rite system (m/s)

  At the end of the fourth training week

• Change from baseline gait speed at the end of the training

  Analysed by the Gait Rite system (m/s)

  At the end of the sixth training week

• Baseline mean double support percentage

  Analysed by the Gait Rite system (0-100%)

  Before training

• Change in mean double support percentage at first training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 1)

• Change in mean double support percentage at second training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the second session of training (day 2)

• Change in mean double support percentage at third training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the second session of training (day 3)

• Change from baseline mean double support percentage at first week

  Analysed by the Gait Rite system (0-100%)

  At the end of the first training week

• Change from baseline mean double support percentage at second week

  Analysed by the Gait Rite system (0-100%)

  At the end of the secondt training week

• Change from baseline mean double support percentage at fourth week

  Analysed by the Gait Rite system (0-100%)

  At the end of the fourth training week

• Change from baseline mean double support percentage at the end of the training

  Analysed by the Gait Rite system (0-100%)

  At the end of the sixth training week

• Change from baseline mean double support percentage at six months

  Analysed by the Gait Rite system (0-100%)

  At 6 months

• Change from baseline mean double support percentage at one year

  Analysed by the Gait Rite system (0-100%)

  At one year

• Change from baseline gait speed at six months

  Analysed by the Gait Rite system (m/s)

  At 6 months

• Change from baseline gait speed at one year

  Analysed by the Gait Rite system (m/s)

  At one year

• Baseline Functional ambulation profile (FAP)

  Analysed by the Gait Rite system (0-100)

  Before training

• Change in FAP at first training session

  Analysed by the Gait Rite system (0-100)

  Before and after the first session of training (day 1)

• Change in FAP at second training session

  Analysed by the Gait Rite system (0-100)

  Before and after the second session of training (day 2)

• Change in FAP at third training session

  Analysed by the Gait Rite system (0-100)

  Before and after the third session of training (day 3)

• Change from baseline FAP at first week

  Analysed by the Gait Rite system (0-100)

  At the end of the first training week

• Change from baseline FAP at second week

  Analysed by the Gait Rite system (0-100)

  At the end of the second training week

• Change from baseline FAP at fourth week

  Analysed by the Gait Rite system (0-100)

  At the end of the fourth training week

• Change from baseline FAP at the end of the training

  Analysed by the Gait Rite system (0-100)

  At the end of the sixth training week

• Change from baseline FAP at six months

  Analysed by the Gait Rite system (0-100)

  At 6 months

• Change from baseline FAP at one year

  Analysed by the Gait Rite system (0-100)

  At one year

• Baseline Mean single support

  Analysed by Gait Rite System (0-100%)

  Before training

• Change in Mean single support at first training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 1)

• Change in Mean single support at second training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 2)

• Change in Mean single support at third training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 3)

• Change from baseline Mean single support at first week

  Analysed by the Gait Rite system (0-100%)

  At the end of the first training week

• Change from baseline Mean single support at second week

  Analysed by the Gait Rite system (0-100%)

  At the end of the second training week

• Change from baseline Mean single support at fourth week

  Analysed by the Gait Rite system (0-100%)

  At the end of the fourth training week

• Change from baseline Mean single support at the end of the training

  Analysed by the Gait Rite system (0-100%)

  At the end of the sixth training week

• Change from baseline Mean single support at six months

  Analysed by the Gait Rite system (0-100%)

  At 6 months

• Change from baseline Mean single support at one year

  Analysed by the Gait Rite system (0-100%)

  At one year

• Baseline Step time

  Analysed by Gait Rite System (0-10s)

  Before training

• Change in Step time at first training session

  Analysed by the Gait Rite system (0-10s)

  Before and after the first session of training (day 1)

• Change in Step time at second training session

  Analysed by the Gait Rite system (0-10s)

  Before and after the second session of training (day 2)

• Change in Step time at third training session

  Analysed by the Gait Rite system (0-10s)

  Before and after the third session of training (day 3)

• Change from baseline Step time at first week

  Analysed by the Gait Rite system (0-10s)

  At the end of the first training week

• Change from baseline Step time at second week

  Analysed by the Gait Rite system (0-10s)

  At the end of the second training week

• Change from baseline Step time at fourth week

  Analysed by the Gait Rite system (0-10s)

  At the end of the fourth training week

• Change from baseline Step time at the end of the training

  Analysed by the Gait Rite system (0-10s)

  At the end of the sixth training week

• Change from baseline Step time at six months

  Analysed by the Gait Rite system (0-10s)

  At 6 months

• Change from baseline Step time at one year

  Analysed by the Gait Rite system (0-10s)

  At one year

• Baseline Step length

  Analysed by Gait Rite System (0-1m)

  Before training

• Change in Step length at first training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the first session of training (day 1)

• Change in Step length at second training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the second session of training (day 2)

• Change in Step length at first training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the third session of training (day 3)

• Change from baseline Step length at first week

  Analysed by the Gait Rite system (0-1m)

  At the end of the first training week

• Change from baseline Step length at second week

  Analysed by the Gait Rite system (0-1m)

  At the end of the second training week

• Change from baseline Step length at fourth week

  Analysed by the Gait Rite system(0-1m)

  At the end of the fourth training week

• Change from baseline Step length at the end of the training

  Analysed by the Gait Rite system (0-1m)

  At the end of the sixth training week

• Change from baseline Step length at six months

  Analysed by the Gait Rite system (0-1m)

  At 6 months

• Change from baseline Step length at one year

  Analysed by the Gait Rite system (0-1m)

  At one year

• Baseline Mean double support

  Analysed by Gait Rite System (0-100%)

  Before training

• Change in Mean double support at first training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 1)

• Change in Mean double support at second training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the second session of training (day 2)

• Change in Mean double support at third training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the third session of training (day 3)

• Change from baseline Mean double support at first week

  Analysed by the Gait Rite system (0-100%)

  At the end of the first training week

• Change from baseline Mean double support at second week

  Analysed by the Gait Rite system (0-100%)

  At the end of the second training week

• Change from baseline Mean double support at fourth week

  Analysed by the Gait Rite system (0-100%)

  At the end of the fourth training week

• Change from baseline Mean double support at the end of the training

  Analysed by the Gait Rite system (0-100%)

  At the end of the sixth training week

• Change from baseline Mean double support at six months

  Analysed by the Gait Rite system (0-100%)

  At 6 months

• Change from baseline Mean double support at one year

  Analysed by the Gait Rite system (0-100%)

  At one year

• Baseline Support base width

  Analysed by Gait Rite System (0-1m)

  Before training

• Change in Support base width at first training session

  Analysed by the Gait Rite system(0-1m)

  Before and after the first session of training (day 1)

• Change in Support base width at second training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the second session of training (day 2)

• Change in Support base width at third training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the third session of training (day 3)

• Change from baseline Support base width at first week

  Analysed by the Gait Rite system (0-1m)

  At the end of the first training week

• Change from baseline Support base width at second week

  Analysed by the Gait Rite system (0-1m)

  At the end of the second training week

• Change from baseline Support base width at fourth week

  Analysed by the Gait Rite system (0-1m)

  At the end of the fourth training week

• Change from baseline Support base width at the end of the training

  Analysed by the Gait Rite system (0-1m)

  At the end of the sixth training week

• Change from baseline Support base width at six months

  Analysed by the Gait Rite system (0-1m)

  At 6 months

• Change from baseline Support base width at one year

  Analysed by the Gait Rite system (0-1m)

  At one year

• Baseline Step width

  Analysed by Gait Rite System (0-1m)

  Before training

• Change in Step width at first training session

  Analysed by the Gait Rite system(0-1m)

  Before and after the first session of training (day 1)

• Change in Step width at second training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the second session of training (day 2)

• Change in Step width at third training session

  Analysed by the Gait Rite system (0-1m)

  Before and after the third session of training (day 3)

• Change from baseline Step width at first week

  Analysed by the Gait Rite system (0-1m)

  At the end of the first training week

• Change from baseline Step width at second week

  Analysed by the Gait Rite system (0-1m)

  At the end of the second training week

• Change from baseline Step width at fourth week

  Analysed by the Gait Rite system (0-1m)

  At the end of the fourth training week

• Change from baseline Step width at the end of the training

  Analysed by the Gait Rite system (0-1m)

  At the end of the sixth training week

• Change from baseline Step width at six months

  Analysed by the Gait Rite system (0-1m)

  At 6 months

• Change from baseline Step width at one year

  Analysed by the Gait Rite system (0-1m)

  At one year

• Baseline Variation coefficient of the plantar support´s lenght

  Analysed by Gait Rite System (0-100%)

  Before training

• Change in Variation coefficient of the plantar support´s lenght at first training sesion

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 1)

• Change in Variation coefficient of the plantar support´s lenght at second training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the first session of training (day 2)

• Change in Variation coefficient of the plantar support´s lenght at third training session

  Analysed by the Gait Rite system (0-100%)

  Before and after the third session of training (day 3)

• Change from baseline Variation coefficient of the plantar support´s lenght at first week

  Analysed by the Gait Rite system (0-100%)

  At the end of the first training week

• Change from baseline Variation coefficient of the plantar support´s lenght at second week

  Analysed by the Gait Rite system (0-100%)

  At the end of the second training week

• Change from baseline Variation coefficient of the plantar support´s lenght at fourth week

  Analysed by the Gait Rite system (0-100%)

  At the end of the fourth training week

• Change from baseline Variation coefficient of the plantar support´s lenght at the end of the training

  Analysed by the Gait Rite system (0-100%)

  At the end of the sixth training week

• Change from baseline Variation coefficient of the plantar support´s lenght at six months

  Analysed by the Gait Rite system (0-100%)

  At 6 months

• Change from baseline Variation coefficient of the plantar support´s lenght at one year

  Analysed by the Gait Rite system (0-100%)

  At one year

Secondary Outcomes (24)

• Baseline Strength

  Before training

• Change from baseline Strength at the end of the training

  At the end of the sixth training week

• Change from baseline Strength at six months

  At 6 months

• Change from baseline Strength at one year

  At one year

• Baseline Spasticity

  Before training

Study Arms (2)

Control

ACTIVE COMPARATOR

Intervention: Control group, with 30 training sessions in robotic orthosis with duration of 30 minutes during 6 weeks. The initial training speed will be the comfortable one for each patient, as assessed by Swinnen.The training progression will consist in a 10% weekly increase in speed, and a 5% weekly reduction of partial weight support.

Device: 30 minutes Lokomat

Experimental

EXPERIMENTAL

Intervention: Experimental group, with 30 training sessions in robotic orthosis with duration of 60 minutes during 6 weeks. The initial training speed will be the comfortable one for each patient, as assessed by Swinnen.The training progression will consist in a 10% weekly increase in speed, and a 5% weekly reduction of partial weight support.

Device: 60 minutes Lokomat

Interventions

30 minutes Lokomat DEVICE

30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 30 minutes. The initial training speed will be the comfortable one for each patient, as assessed by Swinnen (20). The training progression will consist in a 10% weekly increase in speed, and a 5% weekly reduction of partial weight support.

Control

60 minutes Lokomat DEVICE

30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 60 minutes.

Experimental

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Incomplete SCI AIS C or D with at least 6 months of evolution.
• Any etiology
• Able to walk with or without walking aids.
• Properly signed written informed consent.

You may not qualify if:

• Orthopedic conditions like bone instability , arthrodesis
• Metabolic pathology which impedes exercise.
• Audio or visual alterations.
• Own Robotic Orthoses (lokomat) counter-indications: body weight bigger than 135 kg, open lesions in skin of lower extremities or torso, non-cooperative patients, mechanical ventilation or continuum use of oxygen.
• Uncontrolled pain.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Rehabilitación

Mexico City, Mexico City, 14389, Mexico

Location

Related Publications (15)

• Swinnen E, Duerinck S, Baeyens JP, Meeusen R, Kerckhofs E. Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):520-6. doi: 10.2340/16501977-0538.

  PMID: 20549155 BACKGROUND

• Morawietz C, Moffat F. Effects of locomotor training after incomplete spinal cord injury: a systematic review. Arch Phys Med Rehabil. 2013 Nov;94(11):2297-308. doi: 10.1016/j.apmr.2013.06.023. Epub 2013 Jul 9.

  PMID: 23850614 BACKGROUND

• Lucareli PR, Lima MO, Lima FP, de Almeida JG, Brech GC, D'Andrea Greve JM. Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study. Spinal Cord. 2011 Sep;49(9):1001-7. doi: 10.1038/sc.2011.37. Epub 2011 May 3.

  PMID: 21537338 BACKGROUND

• Colombo G, Wirz M, Dietz V. Driven gait orthosis for improvement of locomotor training in paraplegic patients. Spinal Cord. 2001 May;39(5):252-5. doi: 10.1038/sj.sc.3101154.

  PMID: 11438840 BACKGROUND

• de Leon RD, Roy RR, Edgerton VR. Is the recovery of stepping following spinal cord injury mediated by modifying existing neural pathways or by generating new pathways? A perspective. Phys Ther. 2001 Dec;81(12):1904-11.

  PMID: 11736625 BACKGROUND

• Threlkeld AJ, Cooper LD, Monger BP, Craven AN, Haupt HG. Temporospatial and kinematic gait alterations during treadmill walking with body weight suspension. Gait Posture. 2003 Jun;17(3):235-45. doi: 10.1016/s0966-6362(02)00105-4.

  PMID: 12770637 BACKGROUND

• Dobkin B, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI. Neurology. 2006 Feb 28;66(4):484-93. doi: 10.1212/01.wnl.0000202600.72018.39.

  PMID: 16505299 BACKGROUND

• Scivoletto G, Tamburella F, Laurenza L, Torre M, Molinari M. Who is going to walk? A review of the factors influencing walking recovery after spinal cord injury. Front Hum Neurosci. 2014 Mar 13;8:141. doi: 10.3389/fnhum.2014.00141. eCollection 2014.

  PMID: 24659962 BACKGROUND

• Manns PJ, Chad KE. Determining the relation between quality of life, handicap, fitness, and physical activity for persons with spinal cord injury. Arch Phys Med Rehabil. 1999 Dec;80(12):1566-71. doi: 10.1016/s0003-9993(99)90331-3.

  PMID: 10597807 BACKGROUND

• Putzke JD, Richards JS, Hicken BL, DeVivo MJ. Predictors of life satisfaction: a spinal cord injury cohort study. Arch Phys Med Rehabil. 2002 Apr;83(4):555-61. doi: 10.1053/apmr.2002.31173.

  PMID: 11932861 BACKGROUND

• Villiger M, Grabher P, Hepp-Reymond MC, Kiper D, Curt A, Bolliger M, Hotz-Boendermaker S, Kollias S, Eng K, Freund P. Relationship between structural brainstem and brain plasticity and lower-limb training in spinal cord injury: a longitudinal pilot study. Front Hum Neurosci. 2015 May 6;9:254. doi: 10.3389/fnhum.2015.00254. eCollection 2015.

  PMID: 25999842 BACKGROUND

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

  PMID: 16367493 RESULT

• Kirchberger I, Cieza A, Biering-Sorensen F, Baumberger M, Charlifue S, Post MW, Campbell R, Kovindha A, Ring H, Sinnott A, Kostanjsek N, Stucki G. ICF Core Sets for individuals with spinal cord injury in the early post-acute context. Spinal Cord. 2010 Apr;48(4):297-304. doi: 10.1038/sc.2009.128. Epub 2009 Sep 29.

  PMID: 19786973 RESULT

• Zarco-Perinan MJ, Barrera-Chacon MJ, Garcia-Obrero I, Mendez-Ferrer JB, Alarcon LE, Echevarria-Ruiz de Vargas C. Development of the Spanish version of the Spinal Cord Independence Measure version III: cross-cultural adaptation and reliability and validity study. Disabil Rehabil. 2014;36(19):1644-51. doi: 10.3109/09638288.2013.864713. Epub 2013 Dec 9.

  PMID: 24320025 RESULT

• Behrman AL, Lawless-Dixon AR, Davis SB, Bowden MG, Nair P, Phadke C, Hannold EM, Plummer P, Harkema SJ. Locomotor training progression and outcomes after incomplete spinal cord injury. Phys Ther. 2005 Dec;85(12):1356-71.

  PMID: 16305274 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jimena Quinzaños, MSc

  Instituto Nacional de Rehabilitacion

  PRINCIPAL INVESTIGATOR

• Ivett Quiñones, PHD

  Instituto Nacional de Rehabilitacion

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 25, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years from the beginning
• Access Criteria: Authorization by e-mail

Locations

ME (1)