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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000044426
• Date of registration: 19/01/2016
• Prospective Registration: No
• Primary sponsor: Hospital Virgen Macarena
• Public title: 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.
• Scientific title: ‘An early specialized physiotherapy intervention: influence on functional status, respiratory function, respiratory complication and hospitalization rate in Patients with Amyotrophic Lateral Sclerosis’
• Date of first enrolment: 02/01/2012
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12616000044426.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Mrs Anja Hochsprung

• Name: Mrs Anja Hochsprung

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Neurological - Neurodegenerative diseases

Amyotrophic Lateral Sclerosis;
Amyotrophic Lateral Sclerosis

Intervention(s)

An individual sixty minutes intervention of Physiotherapy one per week from the beginning of the disease until the death of the patient.The intervention covers the whole group of deteriorated functions that each patient has:
- Chest physiotherapy to increase or preserve the pulmonary function: re-education of respiratory patterns, use of a volume-oriented device, use of manually assisted and unassisted coughing techniques and finally, use of a cough-assist device.
- Conventional Physiotherapy to preserve the ability to walk, the physical balance and the aerobic capacity: Static Cycle Bike for hands and legs, treadmill with suspension system to preserve the walk function and vibratory platform (Zeptor).
- Conventional Physiotherapy to preserve the whole range of movements: active and passive mobilization, manual therapy as well as stretching.
- Manual Therapy and Kinesiotaping to prevent the pain.
-Electro-stimulation in the swallowing muscles to preserve the swallowing and speech ability.

Primary Outcome(s)

Walking assessed by GAITRiter Systems[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]

Forced Vital Capacity assessed by Spirometry WelchAllyn[Before the intervention and every month during the intervention]

Secondary Outcome(s)

Pain assessed by McGill Pain Questionnaire[Before the intervention and every month during the intervention]

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]

Peak Flow assessed by peak flow meter (Inaladuo).[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]

Rate of Hospitalization assessed by review of hospital records.[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]

Oxygen saturation assessed by pulse oximeter (Quirumed)[Before the intervention and every month during the intervention]

Secondary ID(s)

'Nil know'

Source(s) of Monetary Support

Hospital Virgen Macarena

Ethics review

Status: Approved
Approval date:
Contact:

Comite di Etica de Investigacion (CEI) de centro Hospital Universitario Virgen Macarena.