Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke

Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke

Sponsoren

Hauptsponsor: Tan Tock Seng Hospital

Mitarbeiter: National Medical Research Council (NMRC), Singapore

Quelle Tan Tock Seng Hospital
Kurze Zusammenfassung

Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. In recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for experiments in motor control neuroscience. The H-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of the H-Man is available at NTU.The primary aim of this proposed project is to assess to what extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. The investigators believe that H-Man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a pared down home use model will be assessed in 4 subjects.

The investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the H-Man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the H-Man.

detaillierte Beschreibung

As above

Gesamtstatus Completed
Anfangsdatum July 1, 2014
Fertigstellungstermin March 31, 2018
Primäres Abschlussdatum December 31, 2017
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change from Baseline in Fugl Meyer Assessment of Motor Recovery 0, 3, 6, 12 and 24 weeks after start of intervention
Sekundäres Ergebnis
Messen Zeitfenster
Change from Baseline in Action Research Arm Test 0, 3, 6, 12 and 24 weeks after start of intervention
Einschreibung 44
Bedingung
Intervention

Interventionsart: Device

Interventionsname: H-Man

Beschreibung: H-man is a portable end-effector planar upper limb robot.

Armgruppenetikett: H-Man

Anderer Name: No other names.

Interventionsart: Other

Interventionsname: Additional Conventional Therapy

Beschreibung: Repetitive goals based arm therapy

Armgruppenetikett: Additional Conventional Therapy

Anderer Name: No other names

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging

- Duration post stroke: 3 months to 24 months

- Age 21 to 85 years

- Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power >/= 3/5 and elbow flexion MRC motor power >/= 3/5

- Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50

- And / or associated motor incoordination or motor ataxia

Exclusion Criteria:

- Non stroke related causes of arm motor impairment

- Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy <6 months, unhealed fractures or severe arm pain (visual analogue scale VAS > 5/10, pregnancy

- Inability to tolerate sitting for 90 minutes.

- Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS >5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.

- Severe sensory impairment of affected limb

- Severe visual impairment, hemispatial neglect or homonymous hemianopia

- Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE <26/28)

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: 85 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Chua SG Sui Geok, MBBS,FRCP Principal Investigator Tan Tock Seng Hospital
Ort
Einrichtung: Tan Tock Seng Rehabilitation Centre
Standort Länder

Singapore

Überprüfungsdatum

September 2019

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Tan Tock Seng Hospital

Vollständiger Name des Ermittlers: Chua Sui Geok, Karen

Ermittlertitel: Senior Consultant

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: H-Man

Art: Experimental

Beschreibung: H-Man is a novel, portable, inexpensive end-effector upper limb robot.

Etikette: Additional Conventional Therapy

Art: Active Comparator

Beschreibung: Repetitive goals based arm therapy

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation

Hauptzweck: Other

Maskierung: Single (Outcomes Assessor)

Maskierungsbeschreibung: Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.

Quelle: ClinicalTrials.gov