This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

This study has been terminated.
(Due to a lack of resources and the principal investigator leaving the institution, we stopped the study prior to reaching enrollment target.)
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01618227
First received: June 7, 2012
Last updated: February 2, 2017
Last verified: February 2017
Results First Received: December 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Post-traumatic Stiff Wrists
Interventions: Device: Joint Active Systems (JAS) Static progressive splint
Procedure: Rehabilitation without splinting

  Participant Flow
  Hide 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
Rehabilitation With Static Progressive Splinting

Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.

Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer.

Rehabilitation Without Splinting Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.

Participant Flow:   Overall Study
    Rehabilitation With Static Progressive Splinting   Rehabilitation Without Splinting
STARTED   2   2 
COMPLETED   2   0 
NOT COMPLETED   0   2 



  Baseline Characteristics
  Hide 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
Rehabilitation With Static Progressive Splinting

Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.

Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer.

Rehabilitation Without Splinting Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
Total Total of all reporting groups

Baseline Measures
   Rehabilitation With Static Progressive Splinting   Rehabilitation Without Splinting   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2 100.0%      2 100.0%      4 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (3.5)   53.5  (3.9)   55  (3.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  50.0%      1  25.0% 
Male      2 100.0%      1  50.0%      3  75.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wrist Range of Motion   [ Time Frame: 2 months ]

2.  Secondary:   Wrist Range of Motion   [ Time Frame: 6 months ]

3.  Secondary:   Number of Physical/Occupational Therapy Visits   [ Time Frame: 6 months ]

4.  Secondary:   Number of Additional Surgeries   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Neal Chen
Organization: Massachusetts General Hospital
phone: 617-726-4700
e-mail: nchen1@partners.org



Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01618227     History of Changes
Other Study ID Numbers: 2007P002509
Study First Received: June 7, 2012
Results First Received: December 6, 2016
Last Updated: February 2, 2017