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Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

A Prospective Randomized Trial of Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01618227
Enrollment
4
Registered
2012-06-13
Start date
2008-09-30
Completion date
2015-01-31
Last updated
2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stiff Wrists

Brief summary

Loss of wrist flexion and extension is a common problem after wrist and forearm fractures that may lead to disability and unsatisfactory outcomes after fracture treatment. In many patients, this range of motion loss is caused by stiffness of the soft tissues. Such stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of the soft tissues. By altering the splint's bending angle, one can incrementally increase the force applied on either wrist flexion or extension. There are no data comparing rehabilitation with static-progressive splinting to rehabilitation without static-progressive splinting for the restoration of wrist flexion and extension after wrist or forearm fractures. Primary study hypothesis: Two months after study enrollment patients that use static progressive splinting have better wrist flexion and extension than patients that use standard therapy techniques. Secondary study hypotheses: 1. Six months after study enrollment, subjects that use static progressive splinting have better wrist flexion and extension than those that use standard therapy techniques. 2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative pain thoughts, pain anxiety, and depression. 3. Six months after study enrollment, subjects that use static progressive splinting have had fewer physical/occupational therapy visits than those that use standard therapy techniques. 4. Six months after study enrollment patients that use static progressive splinting have had fewer additional surgeries than patients that use standard therapy techniques. This study will employ a prospective randomized design. Subjects will be invited to enroll during their routine office follow-up visit. Informed consent will be obtained. Subjects will be randomized on a 1:1 ratio to rehabilitation with or without static progressive splinting. All subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. The static progressive splint will be prescribed according to the randomization sequence. 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. Use of the splints will be discontinued at the patient's discretion or when a plateau phase in active range of motion is achieved (defined as no measurable gains in active range of motion achieved in a 30-day period).

Detailed description

Upon enrollment, a form containing demographic and injury-related information will be completed, and the subjects will fill out the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Subjects will be evaluated for negative pain thoughts, pain anxiety, and depression. Study staff will supervise and assist with the questionnaires. Subjects will be evaluated at 2 and 6 months after enrollment during their routine office visits. The DASH questionnaire will be filled out and active wrist motion will be measured using a standard goniometer by a research assistant who will not be involved in the care of the patient. The number of physical/occupational therapy visits, additional surgeries, ease of splint application and use, and splint protocol compliance will be recorded. The investigators intend to study the effectiveness rather than the efficacy of the splint, which means subjects will be free at all times to pursue an alternative treatment course and discontinue splint wear. The investigators will use intention to treat analysis. Radiographs and other diagnostic studies will be obtained at the discretion of the treating surgeon and will not differ from routine clinical care.

Interventions

DEVICEJoint 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.

PROCEDURERehabilitation without splinting

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Less than 45 degrees of wrist extension, flexion, or both. * Between two weeks and six months after a wrist or forearm fracture

Exclusion criteria

* Active infection * Wound problems * Inability to comply with a structured rehabilitation protocol * Burn-related contractures * Primary osteoarthritis * Clinically significant anatomic deformity, implants, or heterotopic bone hindering motion

Design outcomes

Primary

MeasureTime frameDescription
Wrist Range of Motion2 monthsFlexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.

Secondary

MeasureTime frameDescription
Wrist Range of Motion6 monthsFlexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.
Number of Physical/Occupational Therapy Visits6 monthsNumber of physical/occupational therapy visits will be collected from enrollment.
Number of Additional Surgeries6 monthsThe number of additional surgeries will be recorded and compared between groups.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
2
Rehabilitation Without Splinting
Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
2
Total4

Baseline characteristics

CharacteristicRehabilitation Without SplintingRehabilitation With Static Progressive SplintingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Age, Continuous53.5 years
STANDARD_DEVIATION 3.9
56.5 years
STANDARD_DEVIATION 3.5
55 years
STANDARD_DEVIATION 3.9
Region of Enrollment
United States
2 participants2 participants4 participants
Sex: Female, Male
Female
1 Participants0 Participants1 Participants
Sex: Female, Male
Male
1 Participants2 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 20 / 2
serious
Total, serious adverse events
0 / 20 / 2

Outcome results

Primary

Wrist Range of Motion

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

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Rehabilitation With Static Progressive SplintingWrist Range of Motion36.5 degreesStandard Deviation 9.19
Rehabilitation Without SplintingWrist Range of Motion57.5 degreesStandard Deviation 10.6
Secondary

Number of Additional Surgeries

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

Time frame: 6 months

ArmMeasureValue (NUMBER)
Rehabilitation With Static Progressive SplintingNumber of Additional Surgeries0 Number of Additional Surgeries
Secondary

Number of Physical/Occupational Therapy Visits

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Rehabilitation With Static Progressive SplintingNumber of Physical/Occupational Therapy Visits28 visitsStandard Deviation 5.66
Secondary

Wrist Range of Motion

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

Time frame: 6 months

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

ArmMeasureValue (MEAN)Dispersion
Rehabilitation With Static Progressive SplintingWrist Range of Motion45 degreesStandard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026