Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from Baseline of 6-minute walk test
研究概览
简要总结
The investigators evaluated the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
详细描述
Recent studies witnessed how physical exercise may interrupt the devastating decrease of muscle performance in DSP and further experiments are underway to find more exercises for the recovery of motor function impairment. In fact the rehabilitation treatment, that aims at reducing motor disability, preserving gait functions and preventing falling risks, is an interesting therapeutic approach. Literature recommends balance re-training exercises, muscle strengthening, selective stretching and retraining of motor activity.
New technologies produced in the recent decades different devices used in strengthening exercises (electromechanical dynamometers), balance recovery (balance platforms) and gait (analyzing treadmills) have visual feedbacks through which the patients may independently monitor accuracy and intensity of their exercises, being therefore strongly motivated and resulting in a high training intensity. These technologies are often used in rehabilitation of different patients, but are rarely employed for DSP.
The purpose of this case control study was to examine the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
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
- Double (Investigator, Outcomes Assessor)
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
- •The participants need to have a history of diabetes mellitus type 2, >3 years, (i.e., time from the diagnosis or the beginning of first related signs or symptoms),
- •A diagnosis of Distal Sensorimotor Polyneuropathy associated,
- •Able to walk autonomously, eventually with a aid.
排除标准
- •Scoring less than 5 points on the Functional Independence Measure (FIM) (7) locomotion scale,
- •Presenting articular ankyloses, contractures, spasms with important locomotion effects,
- •Presenting bony instability affecting lower limb functionality (unconsolidated fractures, vertebral instability, severe osteoporosis),
- •In presence of attendant clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and different other conditions),
- •In presence of cutaneous lesions at lower limbs,
- •Scoring less than 22 points on the Mini Mental State Examination (MMSE),
- •Exhibit important behavioural diseases involving aggressivity or psychotic disorders.
- •Had received prior interventions for Distal Sensorimotor Polyneuropathy.
结局指标
主要结局
Change from Baseline of 6-minute walk test
时间窗: 1 day after the treatment
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance. The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Change from Baseline of 10-metres walk test
时间窗: 1 day after the treatment
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed. The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
次要结局
- Followup change from Baseline of the Tinetti scale(30 days after the treatment)
- Change from Baseline of the Glycated Hemoglobin (HbA1c)(1 day after the treatment)
- Followup change from Baseline of 6-minute walk test(30 days after the treatment)
- Followup change from Baseline of 10-metres walk test(30 days after the treatment)
- Change from Baseline of the Functional Independence Measure (FIM)(1 day after the treatment)
- Change from Baseline of the Tinetti scale(1 day after the treatment)
- Change from Baseline of the Resting Energy Expenditure (REE)(1 day after the treatment)
- Change from Baseline of the Respiratory Rate (RR)(1 day after the treatment)
- Change from Baseline of the Heart Rate (HR)(1 day after the treatment)
- Change from Baseline of the oxygen saturation (SpO2)(1 day after the treatment)
- Change from Baseline of the maximal oxygen consumption (VO2 max)(1 day after the treatment)
- Change from Baseline of the expired minute volume (Ve)(1 day after the treatment)
- Change from Baseline of the fraction of expired air that is oxygen (FeO2)(1 day after the treatment)
- Change from Baseline of the Systolic Blood Pressure (SBP)(1 day after the treatment)
- Change from Baseline of the Diastolic Blood Pressure (DBP)(1 day after the treatment)
- Followup change from Baseline of the Functional Independence Measure (FIM)(30 days after the treatment)
- Followup change from Baseline of the Resting Energy Expenditure (REE)(30 days after the treatment)
- Followup change from Baseline of the Respiratory Rate (RR)(30 days after the treatment)
- Followup change from Baseline of the Heart Rate (HR)(30 days after the treatment)
- Followup change from Baseline of the oxygen saturation (SpO2)(30 days after the treatment)
- Followup change from Baseline of the maximal oxygen consumption (VO2 max)(30 days after the treatment)
- Followup change from Baseline of the expired minute volume (Ve)(30 days after the treatment)
- Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)(30 days after the treatment)
- Followup change from Baseline of the Systolic Blood Pressure (SBP)(30 days after the treatment)
- Followup change from Baseline of the Diastolic Blood Pressure (DBP)(30 days after the treatment)
- Followup change from Baseline of the Glycated Hemoglobin (HbA1c)(30 days after the treatment)
研究者
Giovanni Taveggia
MD
Habilita, Ospedale di Sarnico