Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001025426
Ethics application status
Approved
Date submitted
4/02/2016
Date registered
2/08/2016
Date last updated
2/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluate the effectiveness of the intervention of a physiotherapy program of sensory motor stimulation in multiple sclerosis.
Scientific title
Effectiveness of a physiotherapy program of sensory motor stimulation on functional state, gait and pain in multiple sclerosis patients.
Secondary ID [1] 288484 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 297536 0
Condition category
Condition code
Neurological 297737 297737 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An individual sixty minutes intervention of physiotherapy one per week for two years
The sensory motor stimulation physiotherapy including functional electrical stimulation (FES)- cycling will involve electrode stimulation to the quadriceps, hamstring, tibialis anterior and gastrocnemius while using Motomed cycling model VIVA 2 which syncchronize with Hasomed Rehamove 2 a FES machine during gait cycling. The parameters will be set with 300 microsecond pulse width, 30 Hz frequency, 35 rpm speed and 70-140 mA intensity. The dynamic balance training program reported here is based on a previously developed mechanical apparatus which is commercially available as the "Balance Trainer", It consists of two parallel bars that are connected to a base `plate via a two-degrees-of-freedom mechanical joint that allow for the physiological movement of a person while standing as well as while performing a single step. The patients perform various tasks during standing on the Balance Trainer and a physiotherapist guiding, correcting and facilitating movement and proper posture of the trunk. The subject can incline to the right, left, foward and backward while therapists monitor the posture of the trunk. This is performed after cycling. The duration spent on each is 20 minutes and there is 10 minutes rest between each exercise.. These sessions are supervised by the physiotherapist. The strategy used to monitor adherence is a daily diary about the exercises.
Intervention code [1] 293834 0
Rehabilitation
Comparator / control treatment
The intervention group program is an individual sixty minutes intervention of physiotherapy one per week for two years.
The control group are patients who are in a waiting list. The control group participants will receive the intervention 6 months follorwing the control group.
Control group
Active

Outcomes
Primary outcome [1] 297264 0
Primary Outcome 1: Gait pattern by GAITRite Systems 'Registered Trademark'.
Timepoint [1] 297264 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Primary outcome [2] 297265 0
Primary Outcome 2: Static and dynamic balance by Balance Trainer software. It is a composite.
Timepoint [2] 297265 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Primary outcome [3] 297266 0
Primary Outcome 3: Quality of life assesed by Musiqol.
Timepoint [3] 297266 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [1] 320515 0
Secondary Outcome 1: Quality of life assessed with Barthel ‘s scale.
Timepoint [1] 320515 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [2] 320517 0
Secondary Outcome 2: Muscle activity assessed by superficial electromyography by Neurotrac ETS.
Timepoint [2] 320517 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [3] 320522 0
Secondary Outcome 3: Pain assessed by McGill Pain Questionnaire.
Timepoint [3] 320522 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [4] 320525 0
Secondary Outcome 4: Spasticity assessed by Ashworth’s
Timepoint [4] 320525 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [5] 320526 0
Secondary Outcome 5: mean Beck depression score.
Timepoint [5] 320526 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [6] 320527 0
Secondary Outcome 6: Fatigue assessed by Modified Fatigue Impact scale (MFIs)
Timepoint [6] 320527 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [7] 320528 0
Secondary Outcome 7: Risk of falls assessed by Falls Efficacy Scale (FES-I).
Timepoint [7] 320528 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention
commencement.
Secondary outcome [8] 320529 0
Secondary Outcome 8: Respiratory function assessed by spirometry WelchAllyn.
Timepoint [8] 320529 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.
Secondary outcome [9] 320530 0
Secondary Outcome 9: Blood oxygen saturation assessed by pulse oximeter (Quirumed).
Timepoint [9] 320530 0
Timepoint: before the intervention and at 1, 3, 7 and 13 months after intervention commencement.

Eligibility
Key inclusion criteria
Key Inclusion Criteria were: diagnosis of Multiple Sclerosis; given written informed consent; ability and willing to comply with the study procedures and the follow-up requirements; given written informed consent.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The Exclusion Criteria were: an immediately vital risk; patients with severe comorbidity different from MS that may pose a risk to mobilization; no ability and willing to comply with the study procedures and the follow-up requirements; psychological or medical disorder comprehension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are derived from hospital unit Multiple Sclerosis, then randomly assigned to an intervention group (I ) or control group (II).

"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence is “MAS Version 2.1 @Glazo Wellcome.”
Sample size: 100
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7575 0
Spain
State/province [1] 7575 0
Seville

Funding & Sponsors
Funding source category [1] 292831 0
Hospital
Name [1] 292831 0
Hospital Universitario Virgen Macarena
Country [1] 292831 0
Spain
Primary sponsor type
Hospital
Name
Hospital Universitario Virgen Macarena
Address
Avenida Doctor Frediani 3, Seville 41071
Country
Spain
Secondary sponsor category [1] 291571 0
Individual
Name [1] 291571 0
Anja Hochsprung
Address [1] 291571 0
Physiotherapist's Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Spain
Country [1] 291571 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294336 0
Comite de Etica de la Investigacion de Centro Hospital Universitario Virgen Macarena.
Ethics committee address [1] 294336 0
Ethics committee country [1] 294336 0
Spain
Date submitted for ethics approval [1] 294336 0
10/08/2012
Approval date [1] 294336 0
10/10/2012
Ethics approval number [1] 294336 0
1896

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63166 0
Miss Anja Hochsprung
Address 63166 0
Physiotherapist's Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 63166 0
Spain
Phone 63166 0
+34 671562074
Fax 63166 0
Email 63166 0
[email protected]
Contact person for public queries
Name 63167 0
Anja Hochsprung
Address 63167 0
Physiotherapist's Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 63167 0
Spain
Phone 63167 0
+34 671562074
Fax 63167 0
Email 63167 0
[email protected]
Contact person for scientific queries
Name 63168 0
Anja Hochsprung
Address 63168 0
Physiotherapist's Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 63168 0
Spain
Phone 63168 0
+34 671562074
Fax 63168 0
Email 63168 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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