New Technologies in the Rehabilitation of Chronic Stroke

Stroke Clinical Trial

— SRTI  

Official title:

Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641651
• Other study ID #: ZHAW-SRTI
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2022
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.

The evaluation focuses on feasibility and cost-benefit analyses

Description:

This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult patients with residual hemiparesis after cerebrovascular accident

• Up to 12 months after the event

• Primary rehabilitation terminated

• Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)

• General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician

• Understand written and spoken German language

Exclusion Criteria:

Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as

• fixed joint contractures limiting range of motion

• non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis

Specific absolute contraindication for the training with any of the respective devices:

• Improper fit of the device, including its harness to relevant extremity(ies)

• Contraindicated training position (standing, sitting)

Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• Rehabilitation technology
Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. The training can take place in an outpatient or inpatient setting. Training will be organized in individual one-to-one or group session

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden
Switzerland	Kliniken Valens	Valens
Switzerland	Rehakliniken Zihlschlacht	Zihlschlacht
Switzerland	Klinik Lengg AG	Zürich

Sponsors (5)

Lead Sponsor	Collaborator
Markus Wirz	Klinik Lengg AG, Klinik Valens, Reha Rheinfelden, Rehaklinik Zihlschlacht AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (35)

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Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3. — View Citation

Jette DU, Warren RL, Wirtalla C. The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Arch Phys Med Rehabil. 2005 Mar;86(3):373-9. — View Citation

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Knecht S, Roßmüller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11. — View Citation

Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30. — View Citation

Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. Epub 2004 Oct 7. Review. — View Citation

Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. — View Citation

Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005. — View Citation

Lang CE, Wagner JM, Edwards DF, Dromerick AW. Upper extremity use in people with hemiparesis in the first few weeks after stroke. J Neurol Phys Ther. 2007 Jun;31(2):56-63. — View Citation

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Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16. Erratum in: N Engl J Med. 2011 Nov 3;365(18):1749. — View Citation

Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27. — View Citation

Masiero S, Poli P, Rosati G, Zanotto D, Iosa M, Paolucci S, Morone G. The value of robotic systems in stroke rehabilitation. Expert Rev Med Devices. 2014 Mar;11(2):187-98. doi: 10.1586/17434440.2014.882766. Epub 2014 Jan 30. Review. — View Citation

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between Scheduled and Performed Trainings	Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.	4 weeks
Secondary	Functional Independence Measurement (FIM) Generic Functional Performance	observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)	Baseline and 4 weeks
Secondary	Stroke Impact Scale (SIS) Recovery	Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items.; each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)	Baseline and 4 weeks
Secondary	Box and Block Test	Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side.; The unit of the measure is the amount of blocks transferred within 60 seconds.	Baseline and 4 weeks
Secondary	Functional Ambulation Categories (FAC)	Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)	Baseline and 4 weeks
Secondary	10m Walk Test= TMT Comfortable	time needed to walk 10 m with Comfortable walking speed	Baseline and 4 weeks
Secondary	Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)	The Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes; scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better	Baseline and 4 weeks
Secondary	Berg Balance Scale (BBS)	Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better	Baseline and 4 weeks