Stroke Clinical Trial
Official title:
Effects of Electromechanical-assisted Gait Training Within an Integrated, Practice-oriented Therapy Approach in Subacute Stroke Patients - a Randomised Controlled (RCT) Trial
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | June 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria: - 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 Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Zurcher RehaZentrum Wald | Wald | Zurich |
Lead Sponsor | Collaborator |
---|---|
Zürcher RehaZentrum Wald |
Switzerland,
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. — View Citation
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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 14;11:CD006073. — View Citation
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. — View Citation
Jørgensen 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. — View Citation
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. Review. — View Citation
Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013 Jul 25;(7):CD006185. doi: 10.1002/14651858.CD006185.pub3. Review. Update in: Cochrane Database Syst Rev. 2017 May 10;5:CD006185. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2005;(4):CD002840. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Walking speed (ICF-level activity): | To assess walking speed the 10mWT is performed. The 10mWT is a simple, highly reliable and valid test for the assessment of walking speed in stroke patients (Tyson & Connell, 2009). It is carried out in patients with a FAC-level >=2. Lower FAC-levels are not tested. | T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion | |
Secondary | Walking capacity (ICF-level activity): | To assess walking capacity the 6minWT is performed. The 6minWT is a simple and valid test which is used to assess maximum walking distance. It shows adequate reliability and excellent validity in stroke patients (Kosak & Smith, 2005). The 6minWT is carried out in patients with FAC-Level >=2. Lower FAC-levels are not tested. | T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion | |
Secondary | Functional Mobility (ICF-level activity): | For the assessment of mobility, the DEMMI is chosen. The DEMMI consists of 17 basic everyday mobility tasks differentiating between 5 conditions (bed, chair, static balance, walking and dynamic balance) (de Morton, Davidson, & Keating, 2008). The DEMMI is a practical, short and valid mobility test for geriatric and stroke patients that is sensitive to detect changes (Braun et al., 2015). | T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion | |
Secondary | Muscular Strength lower extremities (ICF-level structure/function): | Change of lower extremities muscular strength is measured with the Motricity Index (MI). Due to the present intervention studied only the muscle force of the lower limbs will be evaluated (hip flexion, knee extension, ankle dorsiflexion). Previous studies have shown that the MI is a valid, reliable and sensitive tool that is short and easily to apply (Collin & Wade, 1990; Demeurisse, Demol, & Robaye, 1980). | T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion | |
Secondary | Spasticity (ICF-level structure/function): | Quantification of spasticity of the affected lower limb is carried out with the mTS. | T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion | |
Secondary | Reintegration to normal living (ICF-level participation): | For the assessment of the ICF level participation the questionnaire Reintegration to normal living Index (RNLI) is chosen. The instrument can be used to evaluate the degree to which the patient has been able to return to a normal life (Wood-Dauphinee & Williams, 1987). | 3 month after intervention end |
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