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Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01740128
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Spinal Cord Injuries
Paraplegia
Paraparesis
Interventions: Device: Robotic body weight supported treadmill training
Other: Harness-supported multimodal balance training

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Multimodal Then Treadmill Training

Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Treadmill Then Multimodal Training

Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.


Participant Flow:   Overall Study
    Multimodal Then Treadmill Training   Treadmill Then Multimodal Training
STARTED   10   11 
COMPLETED   4   4 
NOT COMPLETED   6   7 
Pregnancy                0                1 
Protocol Violation                1                2 
Lost to Follow-up                2                2 
Withdrawal by Subject                1                0 
Insufficient protocol compliance                2                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Multimodal Then Treadmill Training

Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Treadmill Then Multimodal Training

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Total Total of all reporting groups

Baseline Measures
   Multimodal Then Treadmill Training   Treadmill Then Multimodal Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      11 100.0%      21 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  30.0%      2  18.2%      5  23.8% 
Male      7  70.0%      9  81.8%      16  76.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   9.1%      1   4.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  30.0%      6  54.5%      9  42.9% 
White      6  60.0%      3  27.3%      9  42.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1  10.0%      1   9.1%      2   9.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   10   11   21 


  Outcome Measures

1.  Primary:   Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

2.  Secondary:   Change From Baseline in ISNCSCI Lower Extremity Motor Score.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

3.  Secondary:   Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

4.  Secondary:   Change in Leg Spasticity on Modified Ashworth Scale   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

5.  Secondary:   Change in Gait Speed on 10-meter Walk Test.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

6.  Secondary:   Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

7.  Secondary:   Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

8.  Secondary:   Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

9.  Secondary:   Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.   [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

10.  Secondary:   Change From Baseline in Soleus H-reflex Facilitation.   [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]

11.  Secondary:   Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)   [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Smaller than expected enrollment, high dropout rate.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Noam Y. Harel, MD, PhD
Organization: James J. Peters VAMC
phone: 718-584-9000 ext 1742
e-mail: noam.harel@va.gov


Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01740128     History of Changes
Other Study ID Numbers: B0881-W
5IK2RX000881-03 ( U.S. NIH Grant/Contract )
01407 ( Other Identifier: Bronx VA Medical Center )
SPU-11-077 ( Other Identifier: Bronx VA Medical Center )
First Submitted: November 30, 2012
First Posted: December 4, 2012
Results First Submitted: November 16, 2017
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018