Effects of Robotic Versus Manually-Assisted Locomotor Tra... | NCT00127439

Status Module

Oversight Module

Description Module

Detailed Description

Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support (BWS) and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.

The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training (LT) using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic Assisted Locomotor Training	Experimental	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.	Other: Robotic Assisted Locomotor Training
Manually Assisted Locomotor Training	Experimental	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.	Procedure: Manually Assisted Locomotor Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manually Assisted Locomotor Training	Procedure	The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self Selected Velocity on Treadmill	Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.	12 weeks
Stepping: Foot Trajectory Toe-Off	Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.	12 weeks
Stepping: Foot Trajectory Toe-off % Cycle	The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.	12 weeks
Foot Trajectory Initial Contact	Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.

Eligibility Module

Name	Affiliation	Role
Andrea Behrman, PT PhD	North Florida/South Georgia Veterans Health System	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
North Florida/South Georgia Veterans Health System		Gainesville	Florida	32608	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10869131	Background	Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
9928326	Background	Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.

Label	URL
Click here for more information about this study: Differential Effects of Robotic vs. Manually-Assisted Locomotor Training	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Robotic Assisted Locomotor Training	Robotic Assisted Locomotor Training - The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred using a robotic device to provide assistance for stepping and standing kinematics with partial body weight support on a treadmill.
BG001	Manually Assisted Locomotor Training	Manually Assisted Locomotor Training: The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred on a treadmill with partial body weight support and manual assist from 3-4 trainers to produce stepping and standing kinematics.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG0017 BG00215

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.75± 10.01 BG00137.57± 16.48 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0008 BG0017 BG002

Chronicity (months)

Chronicity = number of months since injury.

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	BG00018.81± 15.97 BG00123.21± 24.84 BG002

Lower Extremity Motor Score (X/50)

: Lower Extremity Motor Score = Strength based on bilateral leg muscle strength across 5 muscle groups: hip flexors, knee extensors, ankle dorsiflexors, long toe extensors, and ankle plantar flexors and scored 0-5 for each muscle group. 0 is the lowest score and 5 is the highest score. 0=total paralysis and 5= active movement, against gravity and normal resistance. Twenty-five (25) is the highest score possible for each lower extremity and thus 50 is the highest score for bilateral limbs.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00040± 9 BG001

Walking of SCI II (x/20)

Walking Index for SCI II - lowest score = 0 and highest score is 20. 0 is does not walk with equipment, bracing or assist and 20 is walks without a brace or device or physical assist for 10 meters.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00012± 4.41 BG001

Overground walking self-selected velocity

Overground walking Self-selected walking speed is provided in meters/sec with usual adult walking speed at 1.2 m/sec.

Mean

Standard Deviation

meters/sec

Title

Denominators

Categories

Title	Measurements
	BG0000.35± 0.21 BG0010.31

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Self Selected Velocity on Treadmill

Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.

Posted

Mean

Standard Deviation

m/s

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
OG001	Manually Assisted Locomotor Training	Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.

Units	Counts
Participants	OG0008 OG0017

Title

Denominators

Categories

Baseline Treadmill Walking Speed

Title	Measurements
	OG0000.24± 0.12 OG0010.22± 0.15

Post-Intervention walking speed

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.05														Non-Inferiority or Equivalence	The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.

Primary

Stepping: Foot Trajectory Toe-Off

Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Primary

Stepping: Foot Trajectory Toe-off % Cycle

The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.

Posted

Mean

Standard Deviation

percentage of gait cycle

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Primary

Foot Trajectory Initial Contact

Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Primary

Foot Trajectory Range (Toe Off to Heel Strike)

Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Units	Counts
Participants

Primary

Propulsion: Propulsive Impulse

Push-off force at toe off in N-s during treadmill stepping

Posted

Mean

Standard Deviation

N-s

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Units	Counts
Participants	OG000

Primary

Kinematics: Minimum Thigh Angle

Greatest thigh angle for hip flexion during stepping

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.

Units

Primary

Kinematics: Minimum Hip Angle - Extension

Hip angle at maximal hip extension during stepping

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Units	Counts
Participants	OG000

Primary

Kinematics: Trunk Angle Mid-Stance

Trunk Angle Mid-Stance - position in degrees

Posted

Mean

Standard Deviation

degrees

12 weeks

ID	Title	Description
OG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
OG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Robotic Assisted Locomotor Training	A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.			0	9	6	9
EG001	Manually Assisted Locomotor Training	A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The therapist and trainers manually provide the appropriate kinematics associated with standing and stepping.			1	10	7	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hospitalized	Blood and lymphatic system disorders		Non-systematic Assessment	Participant hospitalized with elevated temperature and elevated blood pressure. Diagnosed with sepsis in bloodstream; hospitalized over weekend, self-report.	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Hospitalized	Infections and infestations		Systematic Assessment	Infected wound at base of sacrum.	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Dizzy	Vascular disorders	Systematic Assessment	Dizziness upon standing; circulatory	EG0001 events1 affected9 at risk EG0012 events1 affected10 at risk
Skin abrasion	Skin and subcutaneous tissue disorders	Systematic Assessment	Skin abrasion	EG0006 events4 affected9 at risk EG0017 events4 affected10 at risk
Loss of balance/fall	Musculoskeletal and connective tissue disorders	Systematic Assessment	Loss of balance that took subject to the floor, no injury	EG0002 events1 affected9 at risk EG0011 events1 affected10 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	Knee and foot pain	EG0003 events2 affected9 at risk EG0013 events2 affected10 at risk
Colored urine	Renal and urinary disorders	Systematic Assessment	Blood tinged urine	EG0002 events1 affected9 at risk EG0011 events1 affected10 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk
muscle pain groin	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Muscle soreness (leg)	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0002 events1 affected9 at risk EG0010 events0 affected10 at risk
Urinary tract infection	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Headache	General disorders	Non-systematic Assessment		EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment		EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk
Chills	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Not feeling well	General disorders	Non-systematic Assessment		EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk
Pulled back muscle	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	Occurred over weekend; unrelated	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk
Catheter loosens and comes off during training	General disorders	Systematic Assessment	Urine spillage due to incident.	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk

ID	Term
D013119	Spinal Cord Injuries
D009043	Motor Activity

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries
D001519	Behavior