NCT02188628

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

Completed NA Last updated 12 September 2019

What this trial tests

NA trial testing H-Man in Stroke in 44 participants. Completed in 31 March 2018.

Timeline

1 July 2014

Primary endpoint
31 December 2017

31 March 2018

Quick facts

Lead sponsor	Tan Tock Seng Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	44
Start date	1 July 2014
Primary completion	31 December 2017
Estimated completion	31 March 2018
Sites	1 location across Singapore

Drugs / interventions tested

• H-Man
• Additional Conventional Therapy

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Tan Tock Seng Hospital

Who can join

Adults 21 to 85, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke.
   Mehrholz J, Pohl M, Platz T, Kugler J, et al · · 2018 · cited 209× · PMID 30175845 · DOI 10.1002/14651858.cd006876.pub5
2. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke.
   Mehrholz J, Pohl M, Platz T, Kugler J, et al · · 2015 · cited 127× · PMID 26559225 · DOI 10.1002/14651858.cd006876.pub4
3. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands.
   Budhota A, Chua KSG, Hussain A, Kager S, et al · · 2021 · cited 31× · PMID 34149587 · DOI 10.3389/fneur.2021.622014
4. Proprioceptive assessment in clinical settings: Evaluation of joint position sense in upper limb post-stroke using a robotic manipulator.
   Contu S, Hussain A, Kager S, Budhota A, et al · · 2017 · cited 21× · PMID 29161264 · DOI 10.1371/journal.pone.0183257
5. Self-Paced Reaching after Stroke: A Quantitative Assessment of Longitudinal and Directional Sensitivity Using the H-Man Planar Robot for Upper Limb Neurorehabilitation.
   Hussain A, Budhota A, Hughes CM, Dailey WD, et al · · 2016 · cited 11× · PMID 27826223 · DOI 10.3389/fnins.2016.00477
6. Work with me, not for me: Relationship between robotic assistance and performance in subacute and chronic stroke patients.
   Kager S, Hussain A, Budhota A, Dailey WD, et al · · 2019 · cited 3× · PMID 31949919 · DOI 10.1177/2055668319881583