Trial Outcomes & Findings for Study Protocol for CTS and Keyboard Controlled Randomized Trial (NCT NCT02101294)
NCT ID: NCT02101294
Last Updated: 2014-09-29
Results Overview
Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside
Results posted on
2014-09-29
Participant Flow
Participant milestones
| Measure |
Interossei Lumbricals Neuro Interface
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout \[actual home row placement order: asdeihotlrn\], plus substitutions on the upper row \[qwfgjyuk;p\] and bottom row \[zxcvb'm,.\] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness.
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|---|---|
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Overall Study
STARTED
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31
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Interossei Lumbricals Neuro Interface
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout \[actual home row placement order: asdeihotlrn\], plus substitutions on the upper row \[qwfgjyuk;p\] and bottom row \[zxcvb'm,.\] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness.
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|---|---|
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Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Study Protocol for CTS and Keyboard Controlled Randomized Trial
Baseline characteristics by cohort
| Measure |
Interossei Lumbricals Neuro Interface
n=20 Participants
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
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|---|---|
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Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subsideSubjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.
Outcome measures
| Measure |
Length of Time Typing With QWERTY
n=20 Participants
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
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|---|---|
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Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome)
|
71.063 minutes
Standard Deviation 69.320
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PRIMARY outcome
Timeframe: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subsideSubjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure, averaged across the two typing sessions that were FingerRelief.
Outcome measures
| Measure |
Length of Time Typing With QWERTY
n=20 Participants
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
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|---|---|
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Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS
|
98.35 minutes
Standard Deviation 86.541
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SECONDARY outcome
Timeframe: Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subsideBefore and after typing, the subject's wrists were measured with a tape measure. The change score is reported here.
Outcome measures
| Measure |
Length of Time Typing With QWERTY
n=20 Participants
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
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|---|---|
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Measurement of Wrist Swelling Following Cessation of QWERTY Typing
|
0.560 centimeters
Standard Deviation 0.715
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SECONDARY outcome
Timeframe: Pre and PostBefore and after the typing session, the subject's wrist was measured. The mean change score of all participants is reported here.
Outcome measures
| Measure |
Length of Time Typing With QWERTY
n=20 Participants
Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
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|---|---|
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Measurement of Increase in Wrist Swelling Following FingerRelief Typing
|
0.042 centimeters
Standard Deviation 0.872
|
Adverse Events
Interossei Lumbricals Neuro Interface
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place