Complications of Diabetes Mellitus, Diabetic Neuropathies
Conditions
Keywords
Exercise Therapy
Brief summary
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.
Detailed description
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.
Interventions
The length of stride of reference used during the exercise is personalized and depends on the height of patients. Each patient carries out the feedback for 20 minutes with the aim of generating the most symmetric and regular gait. Patients, with the dynamometer, work on strengthening of flexor and extensor muscles with ankle speeds at 90°/sec and 120°/sec. The strengthening technique was performed twice for 10 minutes each time with a 1 minute rest between sets. The session ends with a 20-minute feedback on dynamic balance platform by carrying out exercises in which they need to reach randomly appearing targets. Subjects begin with 12 minutes the first 4 sessions, progress to 16 minutes the next 2 sessions, then 18' (2 sessions), and finally 20', if able, during the last 4 sessions.
When needed, more than on e therapist are employed in the intervention for safety reasons.
Sponsors
Giovanni Taveggia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of 6-minute walk test | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 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. |
| Followup change from Baseline of the Tinetti scale | 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 | — |
| Followup change from Baseline of the Functional Independence Measure (FIM) | 30 days after the treatment | — |
| Followup change from Baseline of 10-metres walk test | 30 days 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. |
Countries
Italy
Outcome results
None listed