A Specialized Physiotherapy Intervention in Patients with Amyotrophic Lateral Sclerosis from the beginning of the disease. Influence of this intervention on functional status, respiratory function, quality of life and hospitalization rate.

Not Applicable

Active, not recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Neurological - Neurodegenerative diseases; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12616000044426
• Lead Sponsor: Hospital Virgen Macarena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Key Inclusion Criteria were: diagnosis of ELA established by El Escorial criteria, including in the category of definite or probable; ability and willing to comply with the study procedures and the follow-up requirements; given written informed consent.

Exclusion Criteria

The Exclusion Criteria were: severe unstable medical condiction (with possibility of life threatening complications), fronto-temporal’s dementia; no ability and not willing to comply with the study procedures and follow-up requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity assessed by Spirometry WelchAllyn[Before the intervention and every month during the intervention];Forced Espiratory Volume assessed by Spirometry WelchAllyn[Before the intervention and every month during the intervention];Walking assessed by GAITRiter Systems[Before the intervention and every month during the intervention]

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed with the Revised Amyotrophic Lateral Sclerosis Functional Rating scale and with the Modified Barthel Index by Granger[Before the intervention and every month during the intervention];Number of Pulmonary Complication assessed with verbal self-report by participant at monthly assessment[Before the intervention and every month during the intervention];Rate of Hospitalization assessed by review of hospital records.[Before the intervention and every month during the intervention];Peak Flow assessed by peak flow meter (Inaladuo).[Before the intervention and every month during the intervention];Oxygen saturation assessed by pulse oximeter (Quirumed)[Before the intervention and every month during the intervention];Muscle activity assesses by Superficial Electromyography assessed by Neurotrac ETS[Before the intervention and every month during the intervention];Pain assessed by McGill Pain Questionnaire[Before the intervention and every month during the intervention]