Quality of Life and Rehabilitation Care in Amyotrofic Lateral Sclerosis.

Completed

• Conditions: Amyotrophic Lateral Sclerosis; muscular disease; neuromuscular disease; 10029317

• Registration Number: NL-OMON39262
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-02-21
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

1. Age between 18 and 80 years
2. A life-expectancy longer than one year
3. Forced Vital Capacity at least 80%
4. Diagnosis of Probable or definite ALS according to the revised El Escorial WFN criteria
5. At least 1 month post-diagnosis ALS
6. Being in the rehabilitation phase; diagnotic phase is completed.
7. Walking-ability with or without a ankle-foot orthotic or stick and cycling-ability on a bicycle ergometer, in that capacity that the intervention is expected to be completed.

Exclusion Criteria

1. Cognitive impairment
2. Insufficient mastery of the Dutch language
3. Disabling co-morbidity interfering with the intervention programs or influencing outcome parameters (including severe cardiopulmonair disease, like chest pain, arrhytmia, pacemaker, cardiac surgery, sever dyspnoea d'effort or emphysema, epileptic seizures, poorly regulted diabetes mellitus or hypertension.
4. Psychological disorder, in that capacity that the intervention could not be completed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life (ALSAQ-40, SF-36), activities (LAPAQ, IPA) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Functional capacity.<br /><br>Patients*, partners* and professionals* expectations of and experiences with<br /><br>the AET intervention.</p><br>