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Mobility Optimization Through Velocity Exercise (MOVE)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT00844558
First received: February 13, 2009
Last updated: May 2, 2016
Last verified: May 2016
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Other: Gait Training
Other: Control

  Participant Flow
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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
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Reporting Groups
  Description
Gait

Gait Training Arm

Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months

Control

Control Group

Control: There is no intervention associated with this arm of the study


Participant Flow:   Overall Study
    Gait   Control
STARTED   36 [1]   22 [2] 
Received Allocated Intervention   33   21 
3 Month Visit   29 [3]   19 [4] 
6 Month Visit   28 [5]   18 [6] 
12 Month Visit   24 [3]   18 [7] 
COMPLETED   24   18 
NOT COMPLETED   12   4 
Withdrawal by Subject                9                2 
Death                1                0 
Protocol Violation                1                1 
Lost to Follow-up                0                1 
Physician Decision                1                0 
[1]
  • Received allocated intervention (n=33)
  • Did not receive allocated intervention (n=3)
[2]
  • Received allocated intervention (n=21)
  • Did not receive allocated intervention (n=1)
[3] Discontinued intervention (n=4)
[4]
  • Lost to follow-up (n=1)
  • Discontinued Intervention (n=1)
[5] Discontinued intervention (n=1)
[6] -Discontinued intervention (n=1)
[7] -Discontinued intervention (n=0)



  Baseline Characteristics
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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.
The objective of this study was to determine whether individualized gait training is more effective than usual care for reducing mobility disability and pain in individuals with symptomatic knee osteoarthritis.

Reporting Groups
  Description
Gait The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
Control The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
Total Total of all reporting groups

Baseline Measures
   Gait   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   22   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.1  (7.3)   69.6  (6.4)   69.3  (7.35) 
Gender 
[Units: Participants]
     
Female   22   10   32 
Male   14   12   26 
Region of Enrollment 
[Units: Participants]
     
United States   36   22   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument   [ Time Frame: 0,3,6, and 12 months ]

2.  Secondary:   Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain   [ Time Frame: 0,3,6 and 12 months ]

3.  Secondary:   Change in KOOS Symptoms   [ Time Frame: 0,3,6 and 12 months ]

4.  Secondary:   Change in Long Distance Corridor Walk (LDCW) Time, Secs   [ Time Frame: 0,3,6 and 12 months ]

5.  Secondary:   Change in Stair Climb Time, Secs   [ Time Frame: 0,3,6, and 12 months ]

6.  Secondary:   Change in Chair Stand Time   [ Time Frame: 0,3,6,and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Neil Segal
Organization: University of Iowa
phone: 3193560737
e-mail: segal-research@uiowa.edu



Responsible Party: Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier: NCT00844558     History of Changes
Other Study ID Numbers: 200807706
K23AG030945-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 13, 2009
Results First Received: July 2, 2015
Last Updated: May 2, 2016