Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Gait speed
研究概览
简要总结
Diabetic Peripheral Neuropathy (DPN) affects approximately half of people with Diabetes Mellitus (DM). Its repercussions on the musculoskeletal system and biomechanics mainly impact balance and locomotor function. Therefore, this study is justified by the need to design effective treatment alternatives for the motor alterations observed in people with DPN. The objective of this study will be to evaluate the effectiveness of an exercise program for the trunk, hip, knee and ankle, consisting of muscle strengthening and sensorimotor training, in the treatment of motor deficits caused by DPN. This will be a single-blind randomized clinical trial in which 64 individuals with type 2 DM and DPN will be randomly distributed between the experimental and control groups. The primary outcome will be the kinematic analysis of gait. The secondary outcomes will be: muscle strength assessed by dynamometry and the 30-second sit-to-stand test (30STS), and functional mobility through the Timed Up and Go (TUG) test. Assessments will be performed before the start of the intervention, at the end of the intervention, and at the one-month follow-up. The experimental group will perform a 12-week proximal/distal exercise program (trunk, hip, knee, and ankle). The control group will perform a distal exercise program (ankle and foot). The proposed exercise program is expected to show consistently positive results compared to the control group.
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
- Single (Outcomes Assessor)
盲法说明
Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2
- •DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
- •Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
- •Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
- •Absence of diabetic foot ulcer (DFU) for at least one month
- •No amputation or at most amputation of fingers, except for the hallux
排除标准
- •Individuals involved in physical training programs simultaneously with the intervention
- •History of surgical intervention in the lower limbs or spine
- •Use of walking assistance devices
- •Diagnosis of severe cardiovascular disorder
- •Diagnosis of other neurological impairments in addition to DPN
- •Presence of dementia or inability to provide consistent information
- •Severe retinopathy
研究组 & 干预措施
Proximal-distal group
The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle).
干预措施: Proximal/distal protocol (Other)
Distal group
The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested.
干预措施: Distal protocol (Other)
结局指标
主要结局
Gait speed
时间窗: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
Adhesive markers will be placed at the following points on the right lower limb: greater trochanter, lateral epicondyle of the femur, lateral malleolus, and head of the fifth metatarsal. Markers will also be placed on the calcaneus of both feet. The participant will walk on a nine-meter track for filming with a digital camera. The CvMob program will be used to analyze self-selected gait speed and fast gait. Speed in m/s will be calculated based on the time it takes the participant to traverse a three-meter distance marked on the track.
次要结局
- Joint angles during gait(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Step length and stride(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Muscle strength(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- 30 second sit to stand test(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
研究者
Vinicius Saura Cardoso
Principal Investigator
Federal University of Piaui