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Proof of efficacy in stroke rehabilitation for a novel home-based technology

Improving hand function in mild-moderate chronic stroke survivors: a mobile phone game pairing repetitive movements with nerve stimulation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69010375
Enrollment
70
Registered
2025-03-28
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of hand function in stroke survivors Nervous System Diseases

Interventions

All participants will make three visits to the laboratory, separated by 4 weeks each (i.e. visits at week 0, week 4 and week 8). On each visit, the following measurements of hand function and neurophy
participants are required to synchronise their movements to these cues, making performance highly reliable in timing. Movements will be made in set of four
on the fourth movement, an electrical stimulus to the ulnar nerve will be given, precisely timed relative to the movement. A custom device will register the grasp movements, and deliver the electrical
it will connect to the mobile device over a Bluetooth connection, allowing input/output to and from the game. Participants will be

Sponsors

Newcastle University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Community based stroke survivor 2. More than 6 months after suffering an ischaemic or haemorrhagic cortical or subcortical stroke of mild or moderate severity (Upper Extremity Fugl-Meyer score 29 or greater)

Exclusion criteria

Exclusion criteria: 1. Aphasia or other language problem making understanding the study and giving consent difficult (this only relates to medical difficulties caused by the stroke; for people with poor English language skills, a suitable translator will be arranged) 2. Cognitive impairment making understanding the nature of the study and giving informed consent difficult 3. Metal implants in the brain or skull, which would be a contraindication for transcranial magnetic brain stimulation (TMS) 4. A history of epilepsy (also a contraindication for TMS) 5. Shoulder subluxation, pain or other musculoskeletal difficulties such as contractures 6. An aversion to loud sounds

Design outcomes

Primary

MeasureTime frame
Hand function will be assessed using the Box and Block Test, which counts the number of wooded blocks which can be transported across a barrier in one minute. This will be measured at each visit. Measures will be made in both most affected and least affected hand.

Secondary

MeasureTime frame
1. Hand function measured using Action Research Arm Test at each visit 2. Impairment measured using the Fugl-Meyer score at each visit 3. Power grip strength measured using a Jamar dynamometer at each visit 4. Pinch grip strength measured using a pinch grip dynamometer at each visit 5. Finger individuation measured using a custom device which measures digit flexion force at each visit 6. Motor evoked potentials in the first dorsal interosseous and flexor digitorum superficialis muscles measured using TMS over the motor cortex at a range of intensities above resting motor threshold, at each visit 7. Intracortical inhibition and facilitation in the first dorsal interosseous muscle measured using TMS over the motor cortex and electrical stimulation of the ulnar nerve at the wrist, at each visit 8. Short-latency afferent inhibition in the first dorsal interosseous muscle measured using TMS over the motor cortex and electrical stimulation of the ulnar nerve at the wrist, at each visit Measures 3, 4 and 5 will be assessed in both the most affected and least affected hands. All other measures will be assessed only in the most affected side. The improvement in all measures from visit 1 and visit 2 will be compared between those patients who used the game over this time, and those who did not. For patients who used the game between visit 1 and 2, the improvement from visit 1 to visit 3 will be used to assess whether there is a long-term benefit of the therapy. For patients who used the game between visit 2 and visit 3, the improvement from visit 2 to visit 3 will provide supplementary information on the efficacy of the therapy.

Countries

England, United Kingdom

Contacts

Public ContactStuart Baker
stuart.baker@newcastle.ac.uk+44 1912088206

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026