Integrated, Practice-oriented Electromechanical-assisted Gait Training in Subacute Stroke Patients

NCT03463746 | Unknown

• 1 other identifier: Lyra
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale: Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious rehabilitation programs 70% of those stroke patients still show limited gait ability after three months. Numerous RCTs have shown the superiority of over ground gait training and electromechanical-assisted gait devices in comparison with conventional over ground gait training alone. (Jan Mehrholz, Elsner, Werner, Kugler, \& Pohl, 2013) However, most of these trials used the electromechanical-assisted gait devices in a very high frequency which is almost impossible to achieve in daily clinical routine. Therefore, the effect of a practice-oriented physical therapy protocol including electromechanical-assisted gait training remains unclear. Objective(s): The aim of this clinical trial is to investigate the effects of an integrated, practice-orientated individual physical therapy protocol with or without electromechanical-assisted gait training in subacute stroke patients, respectively. The effects of both physical therapy protocols will be compared with validated assessments covering the different components of the ICF framework: function, activity and participation. Primary objectives: Effects on gait ability and on basic activities of daily living (ADL). Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle force, spasticity and reintegration to normal living (RNLI). Furthermore, different training-related data are recorded to capture the efficiency (intensity and hassle) of both physical therapy protocols.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Gait ability (ICF-level activity)

  To assess change in gait ability the FAC is performed. The FAC is technically simple, inexpensive, reliable and sensitive to change in the assessment of patients after stroke who cannot walk without personal assistance at the beginning of their inpatient rehabilitation. The FAC provides information about the way of physical (not technical e.g. walking aids, orthosis) assistance that is needed for walking. To assess Change over time the FAC will be assessed three times: before Intervention, immediately after Intervention and 3 months after Intervention.

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion; T3: 3 month after intervention end

• Competence in basic ADL (ICF-level activity):

  To assess change in competence in basic ADL the functional Independence measure (FIM) is performed. To assess change over time the FIM will be assessed three times: before Intervention, immediately after Intervention and 3 months after Intervention.

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion; T3: 3 month after intervention end

Secondary Outcomes (6)

• Walking speed (ICF-level activity):

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion

• Walking capacity (ICF-level activity):

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion

• Functional Mobility (ICF-level activity):

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion

• Muscular Strength lower extremities (ICF-level structure/function):

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion

• Spasticity (ICF-level structure/function):

  T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion

Study Arms (2)

Experimental group (EG)

EXPERIMENTAL

Subacute stroke patients will get standard individual physical therapy 2x/week, 45min and electromechanical-assisted gait training on LYRA® gait trainer 3x/week, 45min.

Device: LYRA® gait trainer

Comparator group (CG)

ACTIVE COMPARATOR

The CG will get standard individual physical therapy 5x/week, 45min without any instrument-based locomotion therapy (i.e. treadmill training, electromechanical/robot-assisted gait training).

Device: Standard individual physical therapy

Interventions

LYRA® gait trainer DEVICE

The EG will get standard individual physical therapy (5x/week, 45min) whereby three sessions of electromechanical-assisted gait training on LYRA® gait trainer.

Experimental group (EG)

Standard individual physical therapy DEVICE

The CG will get standard individual physical therapy (5x/week, 45min) without any instrument-based locomotion therapy (i.e. treadmill training, electromechanical/robot-assisted gait training).

Comparator group (CG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: 18- 80 years
• diagnosis: first-time supratentorial stroke (ischaemic/haemorrhagic)
• time after stroke (at admission): \<42 days
• not able to walk independently (FAC 0-2)
• able to sit unsupported without holding (but with floor contact) on the edge of the bed for at least 2min
• written informed consent

You may not qualify if:

• hip, knee, ankle arthrodesis
• bone instability (non-consolidated fractures, unstable spina column, severe osteoporosis)
• unstable vital functions, e.g. cardio-vascular or pulmonary functions
• severe impaired consciousness functions (ICF b110)
• severe vascular disorders of the lower limb
• severe cognitive deficits (not able to understand and follow test instructions and/or training protocol)
• severely fixed contractures
• mechanical ventilation
• open skin lesions in the area of the torso
• patients with extremly disproportionate growth of legs and/or spinal column (e.g. bone or cartilage dysplasie)
• patients with acute infection
• body weight \> 150kg

Sponsors & Collaborators

• Zürcher RehaZentrum Wald: lead

Study Sites (1)

Zurcher RehaZentrum Wald

Wald, Canton of Zurich, 8636, Switzerland

RECRUITING

Related Publications (8)

• Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013 Jul 25;2013(7):CD006185. doi: 10.1002/14651858.CD006185.pub3.

  PMID: 23888479 BACKGROUND

• Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2003;(3):CD002840. doi: 10.1002/14651858.CD002840.

  PMID: 12917932 BACKGROUND

• Krishnamurthi RV, Feigin VL, Forouzanfar MH, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson LM, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, Risk Factors Study 2010 (GBD 2010); GBD Stroke Experts Group. Global and regional burden of first-ever ischaemic and haemorrhagic stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet Glob Health. 2013 Nov;1(5):e259-81. doi: 10.1016/S2214-109X(13)70089-5. Epub 2013 Oct 24.

  PMID: 25104492 BACKGROUND

• Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.

  PMID: 7811170 BACKGROUND

• Buurke JH, Nene AV, Kwakkel G, Erren-Wolters V, Ijzerman MJ, Hermens HJ. Recovery of gait after stroke: what changes? Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):676-83. doi: 10.1177/1545968308317972.

  PMID: 18971383 BACKGROUND

• French B, Thomas LH, Leathley MJ, Sutton CJ, McAdam J, Forster A, Langhorne P, Price CI, Walker A, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006073. doi: 10.1002/14651858.CD006073.pub2.

  PMID: 17943883 BACKGROUND

• Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.

  PMID: 11321005 BACKGROUND

• Hesse S, Sarkodie-Gyan T, Uhlenbrock D. Development of an advanced mechanised gait trainer, controlling movement of the centre of mass, for restoring gait in non-ambulant subjects. Biomed Tech (Berl). 1999 Jul-Aug;44(7-8):194-201. doi: 10.1515/bmte.1999.44.7-8.194.

  PMID: 10472726 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antonella Palla, MD

  Züricher RehaZentrum Wald

  STUDY CHAIR

Central Study Contacts

Doris Bolt, MSc

CONTACT

(0) 55 256 69 05; doris.bolt@zhreha.ch

Antonella Palla, MD

CONTACT

(0) 55 256 68 01; antonella.palla@zhreha.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only assessors of the primary outcomes will be blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomised-controlled, single-blind trial.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 13, 2018
• Study Start: January 13, 2018
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

CH (1)