AzTrials
AzTrials

Spinal Cord InjuriesNCT02749357

Robotic Gait Training in Spinal Cord Injury

A study testing 30 minutes Lokomat and 60 minutes Lokomat in people with Spinal Cord Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
30 minutes Lokomat and 60 minutes Lokomat
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteMexico
Study dates
May 2016to Aug 2021
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Rehabilitación

    Mexico City, Mexico City, 14389

Other trials in Mexico

About this study

Official title: Effect of Different Programs of Robotic Assisted Gait Training in Individuals With Chronic Motor Incomplete Spinal Cord Injury.

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.

Read more

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.

Read the detailed description

A Spinal cord injury (SCI) is the disruption of the nerve pathways that connect the brain to the rest of the body, causing the cessation of their motor, sensory and vegetative functions. It is considered one of the most devastating clinical conditions affecting the functionality and independence of the individual.

The World Health Organization estimates an annual overall incidence of 40-80 new cases per million, equivalent to 250 000 to 500 000 individuals with spinal cord injury each year. The consequences of the SCI, significantly impair the ability of the patient to perform daily life activities, and their overall quality of life.Decreased mobility is the main element that affects lower satisfaction and quality of life. The improvement of mobility or the ability to move in an energy efficient manner improves the quality of life in patients with SCI.

The recovery of walking function is considered of great relevance both by patients and physicians. The most relevant prognostic factor for functional recovery in SCI patients is the neurological status at the moment of the first examination, considering the neurological level and the severity of the lesion according to the American Spinal Injury Association impairment scale (AIS).

According to Scivoletto, of the patients with American Spinal Injury Association (ASIA) impairment scale A, with thoracic and lumbar lesion only 6.4% achieve functional walking. In patients with ASIA B, have an overall rate of ambulation of 23.5%, ASIA C have 51.4% and ASIA D patients have a prognosis for walking recovery between 80-100% (88.9%).

In another study, Dobkin[8] reported that 35% of individuals classified as AIS B, 92% of subjects AIS C and all subjects AIS D recovered the ability to walk after gait training intervention with partial weight bearing for a period of 8 weeks. However, of all the patients with spinal cord injury, few regain a functional gait capacity, due to a low speed, a decreased step length, cadence and changes in rhythm and coordination.

In fact, spinal cord injury often leads to changes in walking patterns, which are associated with postural changes related to poor ability to transfer bodyweight, alterations in balance and equilibrium. Other important factors in the process of walking recovery include: lack of coordination and development of propulsion, sensory loss, and hyperactive spinal reflexes. These deficiencies are severe enough to delay standing and gait rehabilitation process .

Some of the most important gait abnormalities in individuals who suffer spinal cord injuries are: the inability to stand without assistance, the voluntary movement of joints such as hip hip, knee and ankle, knee hyperextension, inability to move the legs without making compensation mechanisms, foot dragging, changes in weight transfer during walking, lack of coordination, transition among phases of gait, and falls.

That is the reason why many gait training programs have been evaluated. Current modalities of gait training, pretend to activate the locomotor center of the central pattern generator by repetitive gait stimuli, allowing the central nervous system plasticity to create new neural pathways and connections in the spinal cord, making possible walking recovery in patients with spinal cord injury. Evidence favors two gait training modalities: the treadmill with partial weight-support and the robotic-assisted gait. These training modalities provide an improvement in gait parameters and functionality when compared to conventional physiotherapy, as shown in the systematic review by Morawietz and Moffat in which different programs of gait training in patients with SCI AIS C and D of diverse etiology of chronic and acute evolution and any neurological level are compared.

Although the use of treadmill , partial weight-bearing and robotic orthotics are essential in the training of locomotion in SCI patients , little has been published about the progress of the training, clinical decision making and evaluation of progress.[16] Most of the studies on the subject provide only very general criteria to optimize treatment (modifying body weight support and speed training), providing insufficient evidence to guide the training progression in parameters such as training frequency, speed and optimal duration of treatment.

As a result, it is important to develop studies which test training strategies that help to clarify issues related to the amount, intensity, frequency, and progression of training in order to achieve the maximum recovery of gait for individuals with SCI. Accordingly, to determine and compare the effect of different gait training programs will orient the development of more effective training programs.

OBJECTIVE

To determine the effects on gait of different gait training programs using a robotic gait orthosis in individuals with chronic incomplete SCI (AIS C/D).

Specific Objectives

  1. To evaluate changes in functionality of gait and spatiotemporal gait parameters, functional independence, lower limbs muscle force, spasticity and joint range of motion of individuals according to different progression programs.
  2. To determine in the short term (immediately posterior to training program), medium term (6 months) and long term (1 year) effect on individuals' functionality of gait, spatiotemporal gait parameters and functional independence obtained with different gait training programs.
  3. To compare the effect of the two different programs of gait training using a robotic gait orthosis.

METHODS

7.1.- Study Design: Randomized Clinical Trial blinded to observer.

7.2.- Subjects: Subjects from inpatient and outpatient services within the Neurologic Rehabilitation Department of the National Institute of Rehabilitation with SCI AIS C and D, with at least 6 months since injury and able to walk with or without walking aids.

Sample Size

Sample Size was calculated based on improvement on gait velocity reported by previous published studies using the program Epidat 4.

It was calculated that 23 patients are required in order to detect a difference between means of 32.3 cm/s, as reported by Wirz , with a standard deviation of 37.5 cm/s, a power of 80% and a confidence level of 95% On the other hand, Hornby reported a difference between means of 0.36 m/s with a standard deviation of 0.14 m/s, which results on a sample size of 4 subjects per group.

Due these differences, an initial trail will performed with an initial sample size of 4 subjects per group and a new calculation of power of the study will be made in order to determine convenience of sample size or necessity of a bigger sample.

RANDOMIZATION The randomization will be conducted by a digital randomization system with atmospheric noise, available at random.org. Allocation will be done by a person not included in the protocol.

Proceeding

The outpatients that assist to the Spinal Cord Injury Service at the "Instituto Nacional de Rehabilitación" will be randomly assigned to two different groups.. The groups are defined as follow:

  1. Control group, with 30 training sessions in robotic orthosis with duration of 30 minutes during 6 weeks.
  2. Control group, with 30 training sessions in robotic orthosis with duration of 60 minutes during 6 weeks.

Proposed statistical analysis

Descriptive statistics will be carried out with measures of central tendency for quantitative variables and proportions for qualitative variables. In order to analyze differences between groups, co variance analysis will be conducted. We will consider results as statistically significative when p<0.05.

Being tested
30 minutes Lokomat, 60 minutes Lokomat
Keywords
gait, robotic orthosis
Medical subject headings
Spinal Cord Injuries

What participants receive

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

  • 30 minutes LokomatDevice

    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.

  • 60 minutes LokomatDevice

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

Study groups in NCT02749357
Study groupRoleWhat they receive
ControlActive comparatorIntervention: 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.
Receives: Device: 30 minutes Lokomat
ExperimentalExperimentalIntervention: 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.
Receives: Device: 60 minutes Lokomat

What is being measured

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

  1. Baseline Gait speed

    Analysed by the Gait Rite system (m/s)

    Measured: Before training

  2. Change in gait speed at first training session

    Analysed by the Gait Rite system (m/s)

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

  3. Change in gait speed at second training session

    Analysed by the Gait Rite system (m/s)

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

  4. Change in gait speed at third training session

    Analysed by the Gait Rite system (m/s)

    Measured: Before and after the third session of training (day3)

  5. Change from baseline gait speed at first week

    Analysed by the Gait Rite system (m/s)

    Measured: At the end of the first training week

  6. Change from baseline gait speed at second week

    Analysed by the Gait Rite system (m/s)

    Measured: At the end of the second training week

  7. Change from baseline gait speed at fourth week

    Analysed by the Gait Rite system (m/s)

    Measured: At the end of the fourth training week

  8. Change from baseline gait speed at the end of the training

    Analysed by the Gait Rite system (m/s)

    Measured: At the end of the sixth training week

  9. Baseline mean double support percentage

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

    Measured: Before training

  10. Change in mean double support percentage at first training session

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

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

  11. Change in mean double support percentage at second training session

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

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

  12. Change in mean double support percentage at third training session

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

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

  13. Change from baseline mean double support percentage at first week

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

    Measured: At the end of the first training week

  14. Change from baseline mean double support percentage at second week

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

    Measured: At the end of the secondt training week

  15. Change from baseline mean double support percentage at fourth week

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

    Measured: At the end of the fourth training week

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

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

    Measured: At the end of the sixth training week

  17. Change from baseline mean double support percentage at six months

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

    Measured: At 6 months

  18. Change from baseline mean double support percentage at one year

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

    Measured: At one year

  19. Change from baseline gait speed at six months

    Analysed by the Gait Rite system (m/s)

    Measured: At 6 months

  20. Change from baseline gait speed at one year

    Analysed by the Gait Rite system (m/s)

    Measured: At one year

  21. Baseline Functional ambulation profile (FAP)

    Analysed by the Gait Rite system (0-100)

    Measured: Before training

  22. Change in FAP at first training session

    Analysed by the Gait Rite system (0-100)

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

  23. Change in FAP at second training session

    Analysed by the Gait Rite system (0-100)

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

  24. Change in FAP at third training session

    Analysed by the Gait Rite system (0-100)

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

  25. Change from baseline FAP at first week

    Analysed by the Gait Rite system (0-100)

    Measured: At the end of the first training week

  26. Change from baseline FAP at second week

    Analysed by the Gait Rite system (0-100)

    Measured: At the end of the second training week

  27. Change from baseline FAP at fourth week

    Analysed by the Gait Rite system (0-100)

    Measured: At the end of the fourth training week

  28. Change from baseline FAP at the end of the training

    Analysed by the Gait Rite system (0-100)

    Measured: At the end of the sixth training week

  29. Change from baseline FAP at six months

    Analysed by the Gait Rite system (0-100)

    Measured: At 6 months

  30. Change from baseline FAP at one year

    Analysed by the Gait Rite system (0-100)

    Measured: At one year

  31. Baseline Mean single support

    Analysed by Gait Rite System (0-100%)

    Measured: Before training

  32. Change in Mean single support at first training session

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

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

  33. Change in Mean single support at second training session

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

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

  34. Change in Mean single support at third training session

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

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

  35. Change from baseline Mean single support at first week

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

    Measured: At the end of the first training week

  36. Change from baseline Mean single support at second week

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

    Measured: At the end of the second training week

  37. Change from baseline Mean single support at fourth week

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

    Measured: At the end of the fourth training week

  38. Change from baseline Mean single support at the end of the training

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

    Measured: At the end of the sixth training week

  39. Change from baseline Mean single support at six months

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

    Measured: At 6 months

  40. Change from baseline Mean single support at one year

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

    Measured: At one year

  41. Baseline Step time

    Analysed by Gait Rite System (0-10s)

    Measured: Before training

  42. Change in Step time at first training session

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

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

  43. Change in Step time at second training session

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

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

  44. Change in Step time at third training session

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

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

  45. Change from baseline Step time at first week

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

    Measured: At the end of the first training week

  46. Change from baseline Step time at second week

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

    Measured: At the end of the second training week

  47. Change from baseline Step time at fourth week

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

    Measured: At the end of the fourth training week

  48. Change from baseline Step time at the end of the training

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

    Measured: At the end of the sixth training week

  49. Change from baseline Step time at six months

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

    Measured: At 6 months

  50. Change from baseline Step time at one year

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

    Measured: At one year

  51. Baseline Step length

    Analysed by Gait Rite System (0-1m)

    Measured: Before training

  52. Change in Step length at first training session

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

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

  53. Change in Step length at second training session

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

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

  54. Change in Step length at first training session

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

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

  55. Change from baseline Step length at first week

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

    Measured: At the end of the first training week

  56. Change from baseline Step length at second week

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

    Measured: At the end of the second training week

  57. Change from baseline Step length at fourth week

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

    Measured: At the end of the fourth training week

  58. Change from baseline Step length at the end of the training

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

    Measured: At the end of the sixth training week

  59. Change from baseline Step length at six months

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

    Measured: At 6 months

  60. Change from baseline Step length at one year

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

    Measured: At one year

  61. Baseline Mean double support

    Analysed by Gait Rite System (0-100%)

    Measured: Before training

  62. Change in Mean double support at first training session

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

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

  63. Change in Mean double support at second training session

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

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

  64. Change in Mean double support at third training session

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

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

  65. Change from baseline Mean double support at first week

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

    Measured: At the end of the first training week

  66. Change from baseline Mean double support at second week

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

    Measured: At the end of the second training week

  67. Change from baseline Mean double support at fourth week

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

    Measured: At the end of the fourth training week

  68. Change from baseline Mean double support at the end of the training

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

    Measured: At the end of the sixth training week

  69. Change from baseline Mean double support at six months

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

    Measured: At 6 months

  70. Change from baseline Mean double support at one year

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

    Measured: At one year

  71. Baseline Support base width

    Analysed by Gait Rite System (0-1m)

    Measured: Before training

  72. Change in Support base width at first training session

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

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

  73. Change in Support base width at second training session

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

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

  74. Change in Support base width at third training session

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

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

  75. Change from baseline Support base width at first week

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

    Measured: At the end of the first training week

  76. Change from baseline Support base width at second week

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

    Measured: At the end of the second training week

  77. Change from baseline Support base width at fourth week

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

    Measured: At the end of the fourth training week

  78. Change from baseline Support base width at the end of the training

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

    Measured: At the end of the sixth training week

  79. Change from baseline Support base width at six months

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

    Measured: At 6 months

  80. Change from baseline Support base width at one year

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

    Measured: At one year

  81. Baseline Step width

    Analysed by Gait Rite System (0-1m)

    Measured: Before training

  82. Change in Step width at first training session

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

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

  83. Change in Step width at second training session

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

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

  84. Change in Step width at third training session

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

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

  85. Change from baseline Step width at first week

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

    Measured: At the end of the first training week

  86. Change from baseline Step width at second week

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

    Measured: At the end of the second training week

  87. Change from baseline Step width at fourth week

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

    Measured: At the end of the fourth training week

  88. Change from baseline Step width at the end of the training

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

    Measured: At the end of the sixth training week

  89. Change from baseline Step width at six months

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

    Measured: At 6 months

  90. Change from baseline Step width at one year

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

    Measured: At one year

  91. Baseline Variation coefficient of the plantar support´s lenght

    Analysed by Gait Rite System (0-100%)

    Measured: Before training

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

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

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

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

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

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

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

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

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

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

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

    Measured: At the end of the first training week

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

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

    Measured: At the end of the second training week

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

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

    Measured: At the end of the fourth training week

  98. 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%)

    Measured: At the end of the sixth training week

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

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

    Measured: At 6 months

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

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

    Measured: At one year

Secondary outcomes (24)

  1. Baseline Strength

    Muscular tension necessary to overcome a position or resistance Lokomat L-FORCE (Nm)

    Measured: Before training

  2. Change from baseline Strength at the end of the training

    Muscular tension necessary to overcome a position or resistance Lokomat L-FORCE (Nm)

    Measured: At the end of the sixth training week

  3. Change from baseline Strength at six months

    Muscular tension necessary to overcome a position or resistance Lokomat L-FORCE (Nm)

    Measured: At 6 months

  4. Change from baseline Strength at one year

    Muscular tension necessary to overcome a position or resistance (Nm) Lokomat L-FORCE

    Measured: At one year

  5. Baseline Spasticity

    Muscular resistance to passive movement related to speed (Nm/°) L-STIFF at 30, 60 and 90°/s

    Measured: Before training

  6. Change from baseline Spasticity at the end of the training

    Muscular resistance to passive movement related to speed (Nm/°) L-STIFF at 30, 60 and 90°/s

    Measured: At the end of the sixth training week

  7. Change from baseline Spasticity at six months

    Muscular resistance to passive movement related to speed (Nm/°) L-STIFF at 30, 60 and 90°/s

    Measured: At 6 months

  8. Change from baseline Spasticity at one year

    Muscular resistance to passive movement related to speed (Nm/°) L-STIFF at 30, 60 and 90°/s

    Measured: At one year

  9. Baseline Range of motion (ROM)

    Range of motion from an articulation. Lokomat L-ROM (degrees)

    Measured: Before training

  10. Change from baseline Range of motion (ROM) at the end of the training

    Range of motion from an articulation. Lokomat L-ROM(degrees)

    Measured: At the end of the sixth training week

  11. Change from baseline Range of motion (ROM) at six months

    Range of motion from an articulation. Lokomat L-ROM (degrees)

    Measured: At 6 months

  12. Change from baseline Range of motion (ROM) at one year

    Range of motion from an articulation. Lokomat L-ROM (degrees)

    Measured: At one year

  13. Baseline SCIM-III (Spinal Coprd Independence Measure III)

    Spinal Cord Independence Measure III (Amount of independence in self-care, sphincter control, transference and locomotion activities) (0-100)

    Measured: Before training

  14. Change from baseline SCIM-III at the end of the training

    Spinal Cord Independence Measure III (Amount of independence in self-care, sphincter control, transference and locomotion activities) (0-100)

    Measured: At the end of the sixth training week

  15. Change from baseline SCIM-III at six months

    Spinal Cord Independence Measure III (Amount of independence in self-care, sphincter control, transference and locomotion activities) (0-100)

    Measured: At 6 months

  16. Change from baseline SCIM-III at one year

    Spinal Cord Independence Measure III (Amount of independence in self-care, sphincter control, transference and locomotion activities) (0-100)

    Measured: At one year

  17. Baseline Satisfaction with life

    Life satisfaction Questionnaire 9 (LISAT 9)(0-36)

    Measured: Before training

  18. Change from baseline Satisfaction with life at the end of the training

    Life satisfaction Questionnaire 9 (LISAT 9)(0-36)

    Measured: At the end of the sixth training week

  19. Change from baseline Satisfaction with life at six months

    Life satisfaction Questionnaire 9 (LISAT 9)(0-36)

    Measured: At 6 months

  20. Change from baseline Satisfaction with life at one year

    Life satisfaction Questionnaire 9 (LISAT 9) (0-36)

    Measured: At one year

  21. Baseline Functioning, Disability and Health classification

    BRIEF-CORE SET OF THE ICF-CY (International Classification of Functioning, Disability and Health)

    Measured: Before training

  22. Change from baseline Functioning, Disability and Health classification at the end of the training

    BRIEF-CORE SET OF THE ICF-CY (International Classification of Functioning, Disability and Health)

    Measured: At the end of the sixth training week

  23. Change from baseline Functioning, Disability and Health classification at six months

    BRIEF-CORE SET OF THE ICF-CY (International Classification of Functioning, Disability and Health)

    Measured: At 6 months

  24. Change from baseline Functioning, Disability and Health classification at one year

    BRIEF-CORE SET OF THE ICF-CY (International Classification of Functioning, Disability and Health)

    Measured: At one year

Timeline

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

  1. First posted25 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2021
  4. Study completionAug 2021

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
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749357
Sponsor's protocol ID
35/15
Status last verified
Aug 2021
First submitted
13 Apr 2016
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The data could be available by e-mail and in order to ensure confidentiality they will be masked

Publications

  • 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.

    PubMed 20549155

  • 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.

    PubMed 23850614

  • 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.

    PubMed 21537338

  • 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.

    PubMed 11438840

  • 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.

    PubMed 11736625

  • 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.

    PubMed 12770637

  • 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.

    PubMed 16505299

  • 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.

    PubMed 24659962

  • 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.

    PubMed 10597807

  • 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.

    PubMed 11932861

  • 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.

    PubMed 25999842

  • 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.

    PubMed 16367493

  • 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.

    PubMed 19786973

  • 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.

    PubMed 24320025

  • 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.

    PubMed 16305274

Questions about this trial

What is this clinical trial studying?

A study testing 30 minutes Lokomat and 60 minutes Lokomat in people with Spinal Cord Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

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 4 inclusion and 5 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Baseline Gait speed (time frame: Before training). The study lists 100 primary outcomes in all. 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 NCT02749357, which also lists 15 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 Aug 2021.

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