Clinical trial NCT06406569: A Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
Official title: Home RehabGym: a Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Technology-aided
Upper limb rehabilitation
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a pilot, clinical feasibility, assessor-blinded trial to evaluate the feasibility of Home RehabGym concept through deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot.

During the 6 weeks training at home phase, patients will be provided with two devices at any one time: with only the MyoPanda being used by the patient for 6 weeks. The H-Man and ReHandyBot will stay with the patient for 3 weeks (i.e. 21 days) each and then alternate.
Primary purpose: TREATMENT

Brief summary: Due to limited resources such as the low therapist to patient ratio or high costs associated to rehabilitation therapy, providing higher therapy dose to patients after discharge is highly challenging. This often results in non-use of the impaired limb as a result of the decreased therapy dose, causing partial loss of the functional improvements previously gained during early rehabilitation.

In this study, the investigators plan to pilot the HomeRehab Gym concept via the deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot.

Detailed description: Previous research has proven that technology-aided upper limb rehabilitation is non-inferior in terms of feasibility and efficacy when compared to conventional therapy in stroke patients. These rehabilitation devices can be set up as a 'rehabilitation gym' (RehabGym), where patients can interact with several devices that target different body and rehabilitation domains and, thus allows for a holistic and complementary therapy.

Despite recent studies having shown that training with a RehabGym under reduced supervision in a hospital is not only feasible but also equally beneficial in terms of clinical outcomes, however, a RehabGym has never been set up at a patient's home to the best of our knowledge.

This study aims to investigate the feasibility and safety of a RehabGym at home concept using three different upper-limb technologies (H-Man, ReHandyBot, MyoPanda) that are established, clinically tested and allow for on-demand therapy. Objective measures of clinical efficacy will also be examined, and cost-analysis to determine the economic feasibility of a commercial implementation of RehabGym at home in the future will be performed.

Eligibility criteria: Inclusion Criteria:

1. Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging
2. Age 21 to 80 years, both males and females
3. At least 28 days post-stroke
4. Upper limb motor impairment of Fugl-Meyer Assessment (FMA) scale 20 to 50
5. Montreal Cognitive Assessment (MoCA) \> 21/30
6. Ability to sit supported and continuously for 60 minutes
7. Stable home abode with enough space to place technologies
8. Has a carer/next of kin to supervise home-based exercises

Exclusion Criteria:

1. Functional impairment of the upper limb due to other pathologies
2. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers)
3. Anticipated life expectancy of less than 6 months
4. Pacemakers and other active implants
5. Active seizures within 3 months
6. Local factors potentially worsened by intensive technology-aided upper-limb therapy and computer-based training:

   * Spasticity - modified Ashworth Scale MAS \> 2 of any upper limb muscle groups
   * Severe pain in affected arm - Visual Analogue Scale for pain VAS \> 5/10
   * Skin wounds
7. Cognitive impairment precluding study participation
8. Severe visual impairment or visual neglect affecting ability to use technologies
9. History of dementia, depression or behavioural problems
10. Pregnant or lactating females will not be allowed to participate

Primary outcomes:
measure: Compliance Rates
timeFrame: Through study's data collection period, up to 2 years.
Secondary outcomes:
measure: Fugl Meyer Motor Assessment (FMA)
timeFrame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
measure: Action Research Arm Test (ARAT)
timeFrame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
measure: System Usability Scale (SUS)
timeFrame: Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))
measure: Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
timeFrame: Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
measure: Box and Block Test (BBT)
timeFrame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Kuah Wee Keong Christopher
role: PRINCIPAL_INVESTIGATOR
References: