Intensive interdisciplinary specialized rehabilitation or regular physiotherapy for multiple sclerosis? A randomised controlled trial with economic evaluation - 15/10/24

Doi : 10.1016/j.rehab.2024.101898

C Bonnyaud ^1,^2,^⁎ , S Hameau ^3,⁴, R Zory ^5,⁶, M Sznajder ⁷, O Heinzlef ^8,⁹, C Aymard ¹⁰, A Chenet ¹¹, B Médée ¹², M Jacota ⁷, P Gallien ¹³, D Bensmail ^14,¹⁵
Rehabmuscle team¹
N Derridj ^c, I Sanogo ^c, M Fournier Mehouas ^a, A Blanchard-Dauphin ^b
^a Archet hospital, CHU, Nice, 1BP 3079 06202 Nice
^b Pierre Swynghedauw Hospital, CHRU, Lille, Rue André Verhaeghe 59037 Lille Cedex
^c Clinical Research Unit, Ambroise Paré hospital, GHU Paris Saclay, APHP., Boulogne, France, 9 Av. Charles de Gaulle 92100 Boulogne-Billancourt

¹ Motion analysis laboratory, Functional Exploration Department, Raymond Poincaré Hospital, GHU Paris Saclay, APHP, Garches, France, 104 Bld Raymond Poincaré 92380 Garches
² Paris-Saclay University, UVSQ, Research Unit ERPHAN, 78000, Versailles, France, 104 Bld Raymond Poincaré 92380 Garches
³ Inserm, Clinical Investigation Center (CIC 1414), University Hospital Center, Rennes, France, 104 Bld Raymond Poincaré 92380 Garches
⁴ Physical and Rehabilitation medicine Department, University Hospital Center, 35000, Rennes, France, 2 Rue Henri le Guilloux 35000 Rennes
⁵ Université Côte d'Azur, LAMHESS, Nice, France, Bld du Mercantour B.P. 3259 06205 NICE Cedex 03
⁶ Institut universitaire de France, France, 1 rue Descartes 75231 Paris Cedex 05
⁷ Clinical Research Unit, Ambroise Paré hospital, GHU Paris Saclay, APHP, Boulogne, France, 9 Av. Charles de Gaulle 92100 Boulogne-Billancourt
⁸ Department of Neurology, Poissy-Saint-Germain-en-Laye Hospital, Poissy, France, 10 rue Champ Gaillard 78300 Poissy
⁹ CRC SEP IDF Ouest, Poissy-Garches, France, 104 Bld Raymond Poincaré 92380 Garches / 10 rue Champ Gaillard 78300 Poissy
¹⁰ Physical and Rehabilitation medicine Department, Fondation hospitalière Sainte-Marie, Paris, France, 167 rue Raymond Losserand 75014 Paris
¹¹ Physical and Rehabilitation medicine Department, University Hospital Nantes, France, 85 Rue Saint-Jacques 44093 Nantes
¹² Physical medicine and rehabilitation department, CHRU Brest, France, 2 avenue Foch 29609 Brest
¹³ Pole Saint Hélier, Rennes, France, 54 Rue Saint-Hélier, 35000, Rennes
¹⁴ Physical and Rehabilitation medicine Department, Raymond Poincaré Hospital, GHU Paris Saclay, APHP, Garches, France, 104 Bld Raymond Poincaré 92380 Garches
¹⁵ End: icap laboratory, Inserm Unit 1179, UVSQ, France, 2 Av. de la Source de la Bièvre, 78180 Montigny-le-Bretonneux

^⁎Corresponding author: Céline Bonnyaud, Tel: +33 1 71 14 49 21, Laboratoire d'analyse du mouvement, Service des Explorations fonctionnelles, Garches, GHU Paris Saclay, APHP, Unité de Recherche ERPHAN, UVSQ, Paris Saclay, Hôpital Raymond Poincaré 104 Bld Raymond Poincaré 92380, Garches, FranceLaboratoire d'analyse du mouvementService des Explorations fonctionnellesGarchesGHU Paris SaclayAPHPUnité de Recherche ERPHANUVSQParis SaclayHôpital Raymond Poincaré 104 Bld Raymond PoincaréGarches92380France

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Highlights

•	IROSU is Interdisciplinary Rehabilitation in an Outpatient Specialised Unit
•	Strength and quality of life improve more with IROSU than community physiotherapy
•	The sensitivity of the 6-minute walk test is low
•	Improvements after a short rehabilitation program are maintained at 5 months
•	Cost-utility is in favour of the interdisciplinary specialised program

Le texte complet de cet article est disponible en PDF.

Abstract

Background

The benefits of Interdisciplinary Rehabilitation in an Outpatient Specialised Unit (IROSU) have not been determined.

Objectives

To compare the effects of IROSU and physiotherapy in the community on impairment, function and Quality Of Life (QoL) in people with Multiple Sclerosis (pwMS) and to determine the medico-economic impact.

Methods

Pragmatic, multicentre, parallel, randomized (centralised computer-generated randomisation) controlled trial. 148 pwMS were analysed (73 in the IROSU group, 75 in the community group). IROSU included balance, stretching, walking, resistance and endurance training. The 6-Minute Walk Test (6MWT) was the primary outcome. Secondary outcomes were speed over 10m, Timed Up and Go and Stair test, balance (Berg Balance Scale, posturology), knee extensor and flexor strength (isokinetic dynamometer), peak power output (cycling test), fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale), QoL (EuroQol EQ5D3L, SEP59), anxiety and depression (Hospital Anxiety and Depression scale) and Multiple Sclerosis Impact Scale. Evaluations were performed before, after 4 weeks of training and 3 and 6 months after the start by therapists blinded to group allocation. Linear mixed effect models were used (intention-to-treat analysis). Cost-effectiveness and cost-utility ratios were analysed.

Results

6MWT increased similarly in both groups from baseline to M1 (423.8 (126.7) m to 476.0 (119) m IROSU, 404.4 (99.3) m to 440.5 (112.1) m community, P <0.001), to M3 (P <0.001) and to M6 (P = 0.001). Knee extensor strength, power output and QoL-physical health improved significantly more in IROSU group (P <0.05, effect size 0.25-0.61). Many improvements were maintained at the 6-month follow-up. Gain in quality adjusted life years and cost-utility ratios were in favour of IROSU.

Conclusions

Walking distance improved similarly in both groups but this was underpowered. The larger improvements in secondary outcomes and quality-adjusted life years after IROSU, maintained at the 6-month follow-up, suggest pwMS should have access to this program each year.

Trial registration Clinical Trials

NCT01871818

Le texte complet de cet article est disponible en PDF.

Keywords : multiple sclerosis, interdisciplinary rehabilitation, specialised unit, community, follow-up, strength, quality of life

List of abbreviations : 6MWT, 10MWT, BBS, EDSS, EQ-5D-3L, FSS, HAD, HRQOL, IROSU, M1, M3 and M6, MFIS, MS, MSIS-29, MSQoL-54, NMB, pwMS, QALY, QoL, RPE, SEP59, TUG, Wmax, WTP