Trial Outcomes & Findings for Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness (NCT NCT01618227)

Results Overview

Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

2 months

Results posted on

2017-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rehabilitation With Static Progressive Splinting n=2 Participants 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 n=2 Participants Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	53.5 years STANDARD_DEVIATION 3.9 • n=7 Participants	55 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.

Outcome measures

Outcome measures
Measure	Rehabilitation With Static Progressive Splinting n=2 Participants 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 n=2 Participants Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
Wrist Range of Motion	36.5 degrees Standard Deviation 9.19	57.5 degrees Standard Deviation 10.6

SECONDARY outcome

Timeframe: 6 months

Population: Two subjects had the same range of motion at 6 months, therefore SD is 0.

Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.

Outcome measures

Outcome measures
Measure	Rehabilitation With Static Progressive Splinting n=2 Participants 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.
Wrist Range of Motion	45 degrees Standard Deviation 0	—

SECONDARY outcome

Timeframe: 6 months

Number of physical/occupational therapy visits will be collected from enrollment.

Outcome measures

Outcome measures
Measure	Rehabilitation With Static Progressive Splinting n=2 Participants 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.
Number of Physical/Occupational Therapy Visits	28 visits Standard Deviation 5.66	—

SECONDARY outcome

Timeframe: 6 months

The number of additional surgeries will be recorded and compared between groups.

Outcome measures

Outcome measures
Measure	Rehabilitation With Static Progressive Splinting n=2 Participants 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.
Number of Additional Surgeries	0 Number of Additional Surgeries	—

Adverse Events

Rehabilitation With Static Progressive Splinting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rehabilitation Without Splinting

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

Neal Chen

Massachusetts General Hospital

Phone: 617-726-4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place