ESPRESSo: Enhancing spontaneous recovery of hand and arm movement with high intensity therapy beginning one week after stroke

• Register: ANZCTR
• Last refreshed on: 4 November 2024
• Main ID: ACTRN12620000871943
• Date of registration: 31/08/2020
• Prospective Registration: Yes
• Primary sponsor: The University of Auckland
• Public title: ESPRESSo: Enhancing spontaneous recovery of hand and arm movement with high intensity therapy beginning one week after stroke
• Scientific title: Enhancing spontaneous recovery after stroke study (ESPRESSo): A single-site, randomised, controlled, Phase IIa, assessor-blind trial to evaluate the effects of a three week programme of high-intensity, high-dose exploratory arm and hand movements initiated within 1 week of stroke on upper limb motor capacity measured with the Action Research Arm Test..
• Date of first enrolment: 25/02/2021
• Target sample size: 70
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12620000871943.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Prof Winston Byblow

• Name: Prof Cathy Stinear

Key inclusion & exclusion criteria

Inclusion criteria: i. People with monohemispheric ischaemic stroke or intracerebral haemorrhage confirmed by CT or MRI admitted to Auckland City Hospital within the last 7 days
ii. First-ever stroke or previous stroke with no upper limb weakness
iii. At least 18 years old
iv. Received a “Good” or “Excellent” prediction from the Predict Recovery Potential (PREP2) algorithm
v. UE-FM score < 51 at enrolment
vi. Able to give informed consent
vii. Patients treated with intravenous thrombolysis and/or intra-arterial thrombectomy are eligible

Exclusion criteria: i. UE-FM score > 50 at enrolment
ii. Cognition and/or communication impairment precluding informed consent or engagement with the research procedures, as determined by the patient’s clinical team
iii. Received a “Limited” or “Poor” PREP2 prediction
iv. Inability to sit in a chair and perform upper limb exercises
v. Life expectancy less than 12 months, as determined by the patient’s clinical team
vi. Upper limb motor performance limited by pre-existing conditions, such as musculoskeletal disease
vii. Residing out of region precluding in-person assessment
viii. Social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow up assessments


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Stroke - Ischaemic

Physical Medicine / Rehabilitation - Physiotherapy

Stroke;
Stroke

Stroke - Haemorrhagic

Physical Medicine / Rehabilitation - Occupational therapy

Intervention(s)

Participants in the intervention group will complete 90 minutes of upper limb therapy each week day, for three weeks, to complete 15 days of therapy. The therapy can be completed in three 30 minute sessions per day, two 45 minute sessions per day, or one 90 minute session per day, depending on patient preference and the clinical judgement of the treating therapist.

Therapy will be initiated within 7-14 days of stroke and delivered by a trained and registered therapist (physiotherapy and/or occupational therapy). Therapy will involve the patient interacting with video games provided by the MindPod platform. This is a new therapy approach currently available for research, but not more widely available for routine care. While playing the games participants will control the movement of animals on screen by moving their weaker hand and arm. Patients can play the game either seated or standing, depending on their preference and the clinical judgement of the treating therapist. Sessions will be one-on-one, with one participant interacting with the games under the guidance and supervision of one therapist.

For sessions focused on arm movements, patients will control the movements of a dolphin on screen, to make the dolphin swim, jump, catch fish, and avoid sharks. The movements of the patients upper limb will be video captured, no markers will be attached to the patient. This video information is used in real-time by the MindPod platform to transform the patients’ arm movements into movements of the dolphin. This video information also allows the measurement of the amount of movement and amount of time spent moving by each patient in each session, ,for subsequent reporting. Patients with initially moderate to severe upper limb weakness may be fitted with a vest t

Primary Outcome(s)

Action Research Arm Test score (ARAT, maximum 57) will be used to measure upper limb motor capacity.[ 12 weeks post-stroke]

Secondary Outcome(s)

Upper extremity Fugl-Meyer scale score (UE-FM, maximum 66) will be used to measure upper limb motor impairment.[ 26 weeks post-stroke]

Action Research Arm Test score (ARAT, maximum 57) will be used to measure upper limb motor capacity.[ Immediately post-intervention]

Stroke Impact Scale score will be used to evaluate patient-reported quality of life.[ 26 weeks post-stroke]

Upper extremity Fugl-Meyer scale score (UE-FM, maximum 66) will be used to measure upper limb motor impairment.[ Immediately post-intervention]

Modified Rankin scale score will be used to evaluate disability.[ 26 weeks post-stroke]

Upper extremity Fugl-Meyer scale score (UE-FM, maximum 66) will be used to measure upper limb motor impairment.[ 12 weeks post-stroke]

Action Research Arm Test score (ARAT, maximum 57) will be used to measure upper limb motor capacity.[ 26 weeks post-stroke]

Secondary ID(s)

None

Source(s) of Monetary Support

Health Research Council of New Zealand

Secondary Sponsor(s)

Mindmaze, Inc (SA)

Ethics review

Status: Approved
Approval date: 23/09/2020
Contact:

Health and Disability Ethics Committee

Results

• Results available: Yes
• Date Completed: 30/08/2024