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Completed

NCT Number: NCT01518179

Compression Gloves for Distal Radius Fracture

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)

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Key information

Conditions

Distal Radius Fractures Arm Injuries Colles' Fracture Fracture Dislocation Fracture of Lower End of Radius Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Smith's Fracture Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clalit Health Services, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.
  • 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

Treatment and study plan

Made-to-Measure Compression Gloves

Device

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

Routine follow up and treatment

Other

Control

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

  1. Swelling of the hand and fingers (using CM ribbon)

    Time frame: 10 week

    Swelling of the hand and fingers (using CM ribbon)

  2. Range of motion of the fingers and wrist (using Goniomater)

    Time frame: 10 weeks

    Range of motion of the fingers and wrist (using Goniomater)

  3. Strength of the hand (using the Gamar Dynamometer in KG).

    Time frame: 10 weeks

    Strength of the hand (using the Gamar Dynamometer in KG).

  4. Pain (using VAS as part of PRWE)

    Time frame: 10 weeks

    Pain (using VAS as part of PRWE)

  5. Overall satisfaction of using the compression gloves (using self reported questionnaire).

    Time frame: 10 weeks

    Overall satisfaction of using the compression gloves (using self reported questionnaire).

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Collaborators

  • University of Haifa

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2012
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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