The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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).
排除标准
- •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
研究组 & 干预措施
Made-to-Measure Compression Gloves
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
干预措施: Made-to-Measure Compression Gloves (Device)
Control
Routine follow up and treatment
干预措施: Routine follow up and treatment (Other)
结局指标
主要结局
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
时间窗: 1 year
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
次要结局
- Swelling of the hand and fingers (using CM ribbon)(10 week)
- Range of motion of the fingers and wrist (using Goniomater)(10 weeks)
- Strength of the hand (using the Gamar Dynamometer in KG).(10 weeks)
- Pain (using VAS as part of PRWE)(10 weeks)
- Overall satisfaction of using the compression gloves (using self reported questionnaire).(10 weeks)
研究者
Uzi Milman
Director, clinical research unit, Clalit Health Services, Haifa
Clalit Health Services