The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000665538
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: Alfred Health
• Public title: The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke
• Scientific title: The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke
• Date of first enrolment: 27/07/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000665538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Emma Schneider

• Name: Ms Emma Schneider

Key inclusion & exclusion criteria

Inclusion criteria: - Medical diagnosis of stroke
- Presence of hemiparesis/hemiplegia
- Have a upper limb activity limitation (defined as <54 blocks on the Box and Block Test which is 20% reduction in the normative scores for adults aged 20-80 years)
- Have at least grade 1 wrist extension and grade 3 shoulder elevation
Exclusion criteria: - Have severe cognitive and/or language defects, which preclude them from following instructions in training sessions (score greater than or equal to 24 on the Mini Mental Status Examination)
- Have any medical condition that precludes them participating in a rehabilitation program aimed at upper limb activity

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

Health Condition(s) or Problem(s) studied

Stroke - Ischaemic

Neurological - Other neurological disorders

Physical Medicine / Rehabilitation - Occupational therapy

Stroke;Hemiplegia;
Stroke
Hemiplegia

Intervention(s)

Participants will be taught and supported to completed the EXTRA practice protocol for 60 minutes per day, six days per week for four weeks. Each 60 minute practice session will involve 30 minutes of Graded Repetitive Supplementary Program (GRASP) training and 30 minutes of the AbleX program. The EXTRA therapy program will be semi supervised by a qualified occupational therapist in a treatment room or in the patient's hospital room. The intervention period will extend for four weeks or until discharged from the rehabilitation unit (whichever is first; this study will not influence discharge dates which will be set by the treating rehabilitation team).

GRASP is an arm and hand exercise program developed for stroke patients with upper extremity impairments and allows patients to undertake a self-directed arm and hand exercise program. GRASP exercises may include functional tasks, fine motor skills and strengthening exercises. Participants will be asked to start the next day where they left off. Every participant will be started at Level 1 and will go up to the next level when they can complete the program in one quarter of the time required (25 minutes).
The AbleX is a computer based upper limb exercise system shown to be effective in providing repetitive, intense and engaging exercise that improves upper limb function. The AbleX runs thorough a Windows operating system on a laptop. Feedback on performance (accuracy), activity time (adherence) and exercise intensity is automatically captured with the exercise game.

Participants will be asked to record the duration of each practice session. Should participants not complete the required amount of daily practice their reasons for not training will be recorded. Participants can choose for greater or less

Primary Outcome(s)

Upper limb activity measured by the 9-Hole Peg Test[Baseline, week 1, week 2, week 3, week 4 after intervention commencement.]

Upper limb activity measured by the Box and Block Test[Baseline, week 1, week 2, week 3, week 4 after intervention commencement.]

Grip strength measured by hand grip dynamometer (kg)[Baseline, week 1, week 2, week 3, week 4 after intervention commencement.]

Secondary Outcome(s)

Adverse events will be tracked and recorded as per the NHMRC Position Statement. Any adverse event will be mandatorily reported to the Chief Investigator and Ethics Committee. Any adverse events will be recorded and classified according to whether they could be attributed to the therapy provided. There are no known/possible adverse events relating to this study. [Daily, from start to end of intervention period.]

Satisfaction will be measured using the simple question "Would you recommend this program to a friend who had suffered a stroke and couldn't move their arm normally?". We will additionally ask for participant feedback using a qualitative survey that has been designed specifically for this study..[4 weeks after intervention commencement (or the last session, if earlier)]

Participation will be recorded by recording the amount of practice completed/not completed during each individual participant's practice. A Participant Practice Log has been prepared to measure the type of practice, number of sessions, duration of each session, duration of active practice, number of repetitions completed, number of health professionals present at each therapy session, success of each session and any reason for why a practice session was missed pr shorter than the time required.[Six days per week for 4 weeks from study commencement (repeated for each participant recruited).]

Recruitment and consent rates including number of patients admitted with a diagnosis of stroke (screened), number with hemiparesis (eligible), number of people who decline participation (refused) as well as the number of people who commenced the study but opted to stop (study dropouts).[Six days per week, from first participant screened to finish of last participant.]

Secondary ID(s)

Nil known

Secondary Sponsor(s)

La Trobe University

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Health Ethics Committee