Clinical Trial: Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program for Charcot−Marie−Tooth Neuropathy Type 1A (CMT1A)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multicenter Study to Evaluate the Effects on Charcot−Marie−Tooth Neuropathy Type 1A of a Composite Treadmill, Stretching and Proprioceptive Exercise (TreSPE)
Brief Summary: Charcot−Marie−Tooth neuropathy type 1A (CMT1A) is one of the most common inherited neurological disorders. The study will evaluate the efficacy and safety of an innovative rehabilitation protocol constituted by exercises at the treadmill and by a stretching and proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A the study will be multicentric and will comprehend four of the most active clinical centers in the field of CMT, in Italy. People with CMT1A are very motivated in entering rehabilitation protocols because to date there is no effective therapy for this disease. Therefore, the investigators expect a high compliance by the patients. With the present project the investigators plan to clarify several unanswered questions: 1) the efficacy and safety of treadmill over a more conventional protocol; 2) the duration and frequency of any rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of rehabilitation approach in patients with CMT.
Detailed Summary:
A multicentre, prospective, randomised, controlled, single blind study to evaluate the impact of aerobic exercise, based on a tightly controlled program at the treadmill, on the rehabilitation therapy of CMT 1A neuropathy.
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.
Sponsor: University of Genova
Current Primary Outcome:
- Walking ability of patients will be evaluated as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1) ]The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
- Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: at the end of treatment: day 90 (T2) ]The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
- Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: at the end of follow up: day 180 (T3) ]The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Balance will be evaluated through the Berg Scale [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts ]The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
- Balance will be evaluated through the Berg Scale [ Time Frame: at the end of treatment: day 90 (T2) ]The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
- balance will be evaluted through the Berg scale [ Time Frame: at the end of follow up: day 180 (T3) ]The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
- Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1) ]The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
- Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: at the end of treatment: day 90 (T2) ]The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
- Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: at the end of follow up: day 180 (T3) ]The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Original Secondary Outcome: Same as current
Information By: University of Genova
Dates:
Date Received: January 24, 2011
Date Started: February 2011
Date Completion: January 2012
Last Updated: February 3, 2011
Last Verified: October 2010
