Trial Outcomes & Findings for Mechanisms of a Dynamic Stability Approach (NCT NCT05247398)

Results Overview

CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in millimeters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

baseline

Results posted on

2025-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Dynamic Stability Exercise Program Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dynamic Stability Exercise Program Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Mechanisms of a Dynamic Stability Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynamic Stability Exercise Program n=21 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Age, Continuous	59.9 years STANDARD_DEVIATION 9.3
Sex: Female, Male Female	16 Participants
Sex: Female, Male Male	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) White	18 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants

PRIMARY outcome

Timeframe: baseline

CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Subluxation of Thumb Carpometacarpal Joint as Per CAT Scan	.66 millimeters Standard Deviation .99

PRIMARY outcome

Timeframe: 9 weeks post intervention

CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Subluxation of Thumb Carpometacarpal Joint as Per CAT Scan	.24 millimeters Standard Deviation .77

PRIMARY outcome

Timeframe: baseline

Sonographic assessment of thumb carpometacarpal subluxation will occur at the time of participants' baseline CAT scan. The same views, position jig and standardized upper limb postures used for the fluoroscopic assessments will again be employed. The thumb CMC joint sonographic procedures described by Oo et al. and the general guidelines put forth by American Institute of Ultrasound in Medicine will be followed. Long axis views of the dorsal and radial borders of the thumb CMC joint will be visualized via use of the Philips Lumify Portable Sonography Device. In these views, the amount of translation of metacarpal base with respect to trapezium will be quantified in millimeters

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Subluxation of Thumb Carpometacarpal Joint as Per Sonography	.92 millimeters Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline

Disability was measured with the Michigan Hand Outcomes Questionnaire (MHQ), an upper extremity-specific self-report questionnaire assessing symptomology and disability across 6 domains: hand function, activities of daily living, work performance, satisfaction, aesthetics/cosmesis, and pain. Right- and left-hand total and subscale scores are produced. Scores range from 0-100, with higher total scores and scores across the first 5 subscales indicating greater abilities or better results, and lower scores on the last subscale indicating less pain. The MHQ has high reliability, validity, and responsiveness among adults with upper extremity rheumatic conditions including OA. For this study, only the total score of the affected hand was reported. Given the high prevalence of bilateral CMC1 OA, the total score from the dominant hand was selected when bilateral CMC1 OA was present.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Michigan Hand Questionnaire	58.9 score on a scale Standard Deviation 16.6

SECONDARY outcome

Timeframe: 9 weeks

Disability was measured with the Michigan Hand Outcomes Questionnaire (MHQ), an upper extremity-specific self-report questionnaire assessing symptomology and disability across 213 6 domains: hand function, activities of daily living, work performance, satisfaction, aesthetics/cosmesis, and pain. Right- and left-hand total and subscale scores are produced. Scores range from 0-100, with higher total scores and scores across the first 5 subscales indicating greater abilities or better results, and lower scores on the last subscale indicating less pain. The MHQ has high reliability, validity, and responsiveness among adults with upper extremity rheumatic conditions including OA. For this study, only the total score of the affected 219 hand was reported. Given the high prevalence of bilateral CMC1 OA, the total score from the dominant hand was selected when bilateral CMC1 OA was present.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Michigan Hand Questionnaire	76.5 score on a scale Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline

Pain severity was measured with a 0-10 Numerical Pain Rating Scale (NPRS), from which participants rated their pain intensity during daily activities over the last 24 hours, with 0 indicating no pain and 10 indicating the worst imaginable pain. The NPRS was selected because it has been established as a clinically relevant tool in persons with various rheumatic diagnoses including CMC1 OA.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Numerical Pain Rating	4.4 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 9 weeks

Pain severity was measured with a 0-10 Numerical Pain Rating Scale (NPRS), from which participants rated their pain intensity during daily activities over the last 24 hours, with 0 indicating no pain and 10 indicating the worst imaginable pain. The NPRS was selected because it has been established as a clinically relevant tool in persons with various rheumatic diagnoses including CMC1 OA.

Outcome measures

Outcome measures
Measure	Dynamic Stability Exercise Program n=20 Participants Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities. Dynamic Stability Exercise Program: The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Numerical Pain Rating	2.3 score on a scale Standard Deviation 1.4

Adverse Events

Dynamic Stability Exercise Program

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

Corey McGee

University of Minnesota

Phone: 612-626-5645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place