Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients
Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (予想される)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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Bergamo
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Sarnico、Bergamo、イタリア、24067
- Habilita, Ospedale di Sarnico
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：Technological Rehabilitation
Experimental group receives a treatment of: 20 minutes of analyzing treadmill with feedback focused on symmetry and length of stride; 20 minutes of isokinetic dynamometric muscle strengthening of flexor and extensor muscles of tibiotarsal joint; 20 minutes of balance retraining on dynamic balance platform.
Each patient receives 20 sessions over a period of 4 weeks (5 sessions per week).
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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.
他の名前：
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アクティブコンパレータ：Control Rehabilitation
Control group receives the same number of treatment sessions of same duration as those in the experimental group: activities targeted to improve the endurance (instead of analyzing treadmill ), manual exercises of lower limb muscle strengthening, stretching exercises (instead of dynamometer), gait retraining on the floor for 20 minutes and static and dynamic balance exercises in upright position (instead of dynamic balance platform).
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When needed, more than on e therapist are employed in the intervention for safety reasons.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline of 6-minute walk test
時間枠：1 day after the treatment
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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. |
1 day after the treatment
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Change from Baseline of 10-metres walk test
時間枠：1 day after the treatment
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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. |
1 day after the treatment
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Followup change from Baseline of 6-minute walk test
時間枠：30 days after the treatment
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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. |
30 days after the treatment
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Followup change from Baseline of 10-metres walk test
時間枠：30 days after the treatment
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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. |
30 days after the treatment
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Change from Baseline of the Functional Independence Measure (FIM)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Tinetti scale
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Resting Energy Expenditure (REE)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Respiratory Rate (RR)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Heart Rate (HR)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the oxygen saturation (SpO2)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the maximal oxygen consumption (VO2 max)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the expired minute volume (Ve)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the fraction of expired air that is oxygen (FeO2)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Systolic Blood Pressure (SBP)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Diastolic Blood Pressure (DBP)
時間枠：1 day after the treatment
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1 day after the treatment
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Change from Baseline of the Glycated Hemoglobin (HbA1c)
時間枠：1 day after the treatment
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1 day after the treatment
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Followup change from Baseline of the Functional Independence Measure (FIM)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Tinetti scale
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Resting Energy Expenditure (REE)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Respiratory Rate (RR)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Heart Rate (HR)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the oxygen saturation (SpO2)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the maximal oxygen consumption (VO2 max)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the expired minute volume (Ve)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Systolic Blood Pressure (SBP)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Diastolic Blood Pressure (DBP)
時間枠：30 days after the treatment
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30 days after the treatment
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Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
時間枠：30 days after the treatment
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30 days after the treatment
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協力者と研究者
捜査官
捜査官
- 主任研究者：Giovanni Taveggia, MD、Habilita, Ospedale di Sarnico
出版物と役立つリンク
一般刊行物
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
- Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
- Gomes AA, Onodera AN, Otuzi ME, Pripas D, Mezzarane RA, Sacco IC. Electromyography and kinematic changes of gait cycle at different cadences in diabetic neuropathic individuals. Muscle Nerve. 2011 Aug;44(2):258-68. doi: 10.1002/mus.22051.
- Starling JR, Harms BA. Diagnosis and treatment of genitofemoral and ilioinguinal neuralgia. World J Surg. 1989 Sep-Oct;13(5):586-91. doi: 10.1007/BF01658875.
- Ites KI, Anderson EJ, Cahill ML, Kearney JA, Post EC, Gilchrist LS. Balance interventions for diabetic peripheral neuropathy: a systematic review. J Geriatr Phys Ther. 2011 Jul-Sep;34(3):109-16. doi: 10.1519/JPT.0b013e318212659a.
- Fedele D, Comi G, Coscelli C, Cucinotta D, Feldman EL, Ghirlanda G, Greene DA, Negrin P, Santeusanio F. A multicenter study on the prevalence of diabetic neuropathy in Italy. Italian Diabetic Neuropathy Committee. Diabetes Care. 1997 May;20(5):836-43. doi: 10.2337/diacare.20.5.836.
- Aring AM, Jones DE, Falko JM. Evaluation and prevention of diabetic neuropathy. Am Fam Physician. 2005 Jun 1;71(11):2123-8.
- Divisova S, Vlckova E, Hnojcikova M, Skorna M, Nemec M, Dubovy P, Dusek L, Jarkovsky J, Belobradkova J, Bednarik J. Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. J Peripher Nerv Syst. 2012 Sep;17(3):341-50. doi: 10.1111/j.1529-8027.2012.00420.x.
- Spencer RJ, Wendell CR, Giggey PP, Katzel LI, Lefkowitz DM, Siegel EL, Waldstein SR. Psychometric limitations of the mini-mental state examination among nondemented older adults: an evaluation of neurocognitive and magnetic resonance imaging correlates. Exp Aging Res. 2013;39(4):382-97. doi: 10.1080/0361073X.2013.808109.
- Nascimento LR, Caetano LC, Freitas DC, Morais TM, Polese JC, Teixeira-Salmela LF. Different instructions during the ten-meter walking test determined significant increases in maximum gait speed in individuals with chronic hemiparesis. Rev Bras Fisioter. 2012 Apr;16(2):122-7. doi: 10.1590/s1413-35552012005000008. Epub 2012 Mar 1. English, Portuguese.
- van Sloten TT, Savelberg HH, Duimel-Peeters IG, Meijer K, Henry RM, Stehouwer CD, Schaper NC. Peripheral neuropathy, decreased muscle strength and obesity are strongly associated with walking in persons with type 2 diabetes without manifest mobility limitations. Diabetes Res Clin Pract. 2011 Jan;91(1):32-9. doi: 10.1016/j.diabres.2010.09.030. Epub 2010 Oct 20.
- Thomas T, Schreiber G. Acute-phase response of plasma protein synthesis during experimental inflammation in neonatal rats. Inflammation. 1985 Mar;9(1):1-7. doi: 10.1007/BF00915406.
- Corriveau H, Prince F, Hebert R, Raiche M, Tessier D, Maheux P, Ardilouze JL. Evaluation of postural stability in elderly with diabetic neuropathy. Diabetes Care. 2000 Aug;23(8):1187-91. doi: 10.2337/diacare.23.8.1187.
研究記録日
主要日程の研究
研究開始
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
最初の投稿
学習記録の更新
投稿された最後の更新 (見積もり)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
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