Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program for Charcot-Marie-Tooth Neuropathy Type 1A (CMT1A)
NCT ID: NCT01289704
Last Updated: 2011-02-04
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2011-02-28
2012-01-31
Brief Summary
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Detailed Description
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Comparing aerobic training at the treadmill combined with respiratory physiotherapy, stretching and proprioceptive exercises (TreSPE- treated group) with a more conventional treatment only composed by respiratory physiotherapy, stretching and proprioceptive exercises (SPE- control group) will provide information on the impact of Treadmill in CMT1A.
92 patients (23 per centre) will be enrolled and randomly assigned to TreSPE (n = 46) or to SPE (n = 46). Both groups will be treated for three months and followed up for six months.
No serious side effects are expected with TreSPE, as also suggested by our preliminary results. For safety reasons blood pressure (BP), heart rate (HR) and an electrocardiogram will be recorded during the rehabilitation treatment when the treating physician considers it necessary. The patients will be allowed, if needed, to hold at the parallel bars of the treadmill during exercise. According to the American Thoracic Society (ATS) guidelines the cardiopulmonary exercise test will be interrupted if BP raises at 240/120 and/or HR to 220-patients age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TreSPE
Treatment with treadmill, proprioceptive and stretching exercises
TreSPE
1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
SPE
Proprioceptive and stretching exercises
TreSPE
1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
SPE
1. Respiratory Physiotherapy for 20', consisting of Positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training according to the Mèzières technique, for the other 10'.
2. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors longus and brevis, both at the bed and in a static position.
3. Proprioceptive and postural kinesitherapy according to the neurocognitive method.
4. Balance Exercising consists of exercises carried on by moving bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handlebar preventing falls.
Interventions
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TreSPE
1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
SPE
1. Respiratory Physiotherapy for 20', consisting of Positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training according to the Mèzières technique, for the other 10'.
2. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors longus and brevis, both at the bed and in a static position.
3. Proprioceptive and postural kinesitherapy according to the neurocognitive method.
4. Balance Exercising consists of exercises carried on by moving bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handlebar preventing falls.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Genetic confirmation (17p112 chromosome duplication)
* Age 18 - 70 years old
* Ability to accomplish the primary outcome measure (10 meter walking test) without support, with or without ankle foot orthoses (AFO)
* Ability to walk on a treadmill on a horizontal plane for 20 minutes at a speed of 1.5 km/h with or without support at the bars
* Score at the Mobility Scale between 2 and 11
* Signed written informed consent to participate
Exclusion Criteria
* Other associated causes of neuropathy
* Vestibular affections, psychiatric, cardiovascular and lung disorders or severe arthropathic changes in the lower limbs
* Non ambulating patients or patients always requiring even monolateral support to walk
* Other neurological disorders
18 Years
70 Years
ALL
Yes
Sponsors
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University of Genova
OTHER
Responsible Party
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Neuroscience, Ophtalmology and Genetic Departement
Principal Investigators
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Angelo E Schenone, MD
Role: PRINCIPAL_INVESTIGATOR
University of Genova
Locations
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University of Genoa
Genoa, , Italy
I.R.C.C.S. Foundation, Besta Institute
Milan, , Italy
Don Carlo Gnocchi Foundation
Rome, , Italy
Departement of Neurological and Visual Sciences, University of Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Grandis M, Shy ME. Current Therapy for Charcot-Marie-Tooth Disease. Curr Treat Options Neurol. 2005 Jan;7(1):23-31. doi: 10.1007/s11940-005-0003-5.
Young P, De Jonghe P, Stogbauer F, Butterfass-Bahloul T. Treatment for Charcot-Marie-Tooth disease. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD006052. doi: 10.1002/14651858.CD006052.pub2.
Passage E, Norreel JC, Noack-Fraissignes P, Sanguedolce V, Pizant J, Thirion X, Robaglia-Schlupp A, Pellissier JF, Fontes M. Ascorbic acid treatment corrects the phenotype of a mouse model of Charcot-Marie-Tooth disease. Nat Med. 2004 Apr;10(4):396-401. doi: 10.1038/nm1023. Epub 2004 Mar 21.
Pareyson D, Schenone A, Fabrizi GM, Santoro L, Padua L, Quattrone A, Vita G, Gemignani F, Visioli F, Solari A; CMT-TRIAAL Group. A multicenter, randomized, double-blind, placebo-controlled trial of long-term ascorbic acid treatment in Charcot-Marie-Tooth disease type 1A (CMT-TRIAAL): the study protocol [EudraCT no.: 2006-000032-27]. Pharmacol Res. 2006 Dec;54(6):436-41. doi: 10.1016/j.phrs.2006.09.001. Epub 2006 Sep 9.
Carter GT, Han JJ, Mayadev A, Weiss MD. Modafinil reduces fatigue in Charcot-Marie-Tooth disease type 1A: a case series. Am J Hosp Palliat Care. 2006 Oct-Nov;23(5):412-6. doi: 10.1177/1049909106292169.
Aitkens SG, McCrory MA, Kilmer DD, Bernauer EM. Moderate resistance exercise program: its effect in slowly progressive neuromuscular disease. Arch Phys Med Rehabil. 1993 Jul;74(7):711-5. doi: 10.1016/0003-9993(93)90031-5.
Kilmer DD, McCrory MA, Wright NC, Aitkens SG, Bernauer EM. The effect of a high resistance exercise program in slowly progressive neuromuscular disease. Arch Phys Med Rehabil. 1994 May;75(5):560-3.
van Pomeren M, Selles RW, van Ginneken BT, Schreuders TA, Janssen WG, Stam HJ. The hypothesis of overwork weakness in Charcot-Marie-Tooth: a critical evaluation. J Rehabil Med. 2009 Jan;41(1):32-4. doi: 10.2340/16501977-0274.
Carter GT, Abresch RT, Fowler WM Jr, Johnson ER, Kilmer DD, McDonald CM. Profiles of neuromuscular diseases. Hereditary motor and sensory neuropathy, types I and II. Am J Phys Med Rehabil. 1995 Sep-Oct;74(5 Suppl):S140-9. doi: 10.1097/00002060-199509001-00008.
Carter GT, Kilmer DD, Bonekat HW, Lieberman JS, Fowler WM Jr. Evaluation of phrenic nerve and pulmonary function in hereditary motor and sensory neuropathy, type I. Muscle Nerve. 1992 Apr;15(4):459-62. doi: 10.1002/mus.880150407.
Sackley C, Disler PB, Turner-Stokes L, Wade DT. Rehabilitation interventions for foot drop in neuromuscular disease. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD003908. doi: 10.1002/14651858.CD003908.pub2.
Solari A, Laura M, Salsano E, Radice D, Pareyson D; CMT-TRIAAL Study Group. Reliability of clinical outcome measures in Charcot-Marie-Tooth disease. Neuromuscul Disord. 2008 Jan;18(1):19-26. doi: 10.1016/j.nmd.2007.09.006. Epub 2007 Oct 26.
Florence JM, Hagberg JM. Effect of training on the exercise responses of neuromuscular disease patients. Med Sci Sports Exerc. 1984 Oct;16(5):460-5. doi: 10.1249/00005768-198410000-00007.
Jones DR, Speier J, Canine K, Owen R, Stull GA. Cardiorespiratory responses to aerobic training by patients with postpoliomyelitis sequelae. JAMA. 1989 Jun 9;261(22):3255-8.
Aitkens S, Kilmer DD, Wright NC, McCrory MA. Metabolic syndrome in neuromuscular disease. Arch Phys Med Rehabil. 2005 May;86(5):1030-6. doi: 10.1016/j.apmr.2004.09.012.
Pfeiffer G, Wicklein EM, Ratusinski T, Schmitt L, Kunze K. Disability and quality of life in Charcot-Marie-Tooth disease type 1. J Neurol Neurosurg Psychiatry. 2001 Apr;70(4):548-50. doi: 10.1136/jnnp.70.4.548.
Vinci P, Serrao M, Millul A, Deidda A, De Santis F, Capici S, Martini D, Pierelli F, Santilli V. Quality of life in patients with Charcot-Marie-Tooth disease. Neurology. 2005 Sep 27;65(6):922-4. doi: 10.1212/01.wnl.0000176062.44360.49.
Shy ME, Blake J, Krajewski K, Fuerst DR, Laura M, Hahn AF, Li J, Lewis RA, Reilly M. Reliability and validity of the CMT neuropathy score as a measure of disability. Neurology. 2005 Apr 12;64(7):1209-14. doi: 10.1212/01.WNL.0000156517.00615.A3.
Graham RC, Hughes RA. Clinimetric properties of a walking scale in peripheral neuropathy. J Neurol Neurosurg Psychiatry. 2006 Aug;77(8):977-9. doi: 10.1136/jnnp.2005.081497. Epub 2006 Mar 30.
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.
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Related Links
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Acmt-Rete is a non-profit organization made by a group of patients to help the CMT community and to promote research in the field of hereditary neuropathies
Other Identifiers
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GUP09013
Identifier Type: -
Identifier Source: org_study_id
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