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Compression Gloves for Distal Radius Fracture

The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01518179
Enrollment
35
Registered
2012-01-25
Start date
2012-04-30
Completion date
2018-12-31
Last updated
2019-01-31

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

Conditions

Colles' Fracture, Distal Radius Fractures, Fracture of Lower End of Radius, Smith's Fracture

Keywords

Colles' Fracture, Compression Bandages, Occupational therapy, Rehabilitation, Smith's fracture

Brief summary

Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength. Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF). This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF. Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture. ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures): S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4). S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)

Detailed description

Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.

Interventions

DEVICEMade-to-Measure Compression Gloves

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

OTHERRoutine follow up and treatment

Control

Sponsors

University of Haifa
CollaboratorOTHER
Clalit Health Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna. 2. Patients who demonstrate at enrolment at least two of the following: * Pain, * limited range of motion of the fingers and the wrist, * limited strength (weakness of the hand/fingers), * swelling /edema, * Limited hand functions during performance of Activities of Daily Living (ADL).

Exclusion criteria

* Neuropathy * Peripheral vascular disease * End stage renal disease * Previous impairment of fingers/wrist range of motion. * Previous Lymphedema of the injured hand * Receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids). * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).1 yearFunctional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).

Secondary

MeasureTime frameDescription
Swelling of the hand and fingers (using CM ribbon)10 weekSwelling of the hand and fingers (using CM ribbon)
Range of motion of the fingers and wrist (using Goniomater)10 weeksRange of motion of the fingers and wrist (using Goniomater)
Strength of the hand (using the Gamar Dynamometer in KG).10 weeksStrength of the hand (using the Gamar Dynamometer in KG).
Pain (using VAS as part of PRWE)10 weeksPain (using VAS as part of PRWE)
Overall satisfaction of using the compression gloves (using self reported questionnaire).10 weeksOverall satisfaction of using the compression gloves (using self reported questionnaire).

Countries

Israel

Outcome results

None listed

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