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A new dose-finding trial design to identify the optimal therapeutic dose of an upper limb intervention for people after stroke

Establishing a feasible optimal therapeutic dose using a new methodology for stroke rehabilitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23054430
Enrollment
24
Registered
2014-04-15
Start date
2014-03-01
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

Upper limb training task: In detail this intervention is focussed on extension and abduction movements of the fingers and thumb of the participants' paretic hand against a tailored resistance applied

Sponsors

University of East Anglia (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18+ years 2. Have presence of moderate upper limb paresis/impairment defined as participants able to open and close their paretic hand six times in one minute but unable to do this 25 times in one minute, from starting position of thumb and finger tips close with an extra, extra, light resistance band placed around fingers and thumb 3. Able to imitate action with the non­paretic upper limb. This will be assessed by the Research Therapist 4. Be discharged from stroke rehabilitation services

Exclusion criteria

Exclusion criteria: Participant should not receive therapy to improve upper limb motor function

Design outcomes

Primary

MeasureTime frame
The commercial therapy device the Cando Digit-Extend Finger Exerciser has been chosen to test participants? motor learning and strength improvement due to its similarity with the training task. The Cando Digit-Extend is a professional but easy device. For this study, the device will be used to test the extensor mechanism of all fingers of the paretic hand. Participants will insert the fingers and thumb of their paretic hand in the plastic frame and open their hand against a coded resistance band. With the Cando Digit-Extend training intensity level (resistance levels or exercise effort) can be easily changed using the five coded resistance bands provided (beige xxlight, yellow x-light, red light, green medium and blue hard). There will be two parts to the measure (mean time 10 minutes): 1. The number of times a participant can extend their fingers (open and close their paretic hand) against the lightest resistance band in one minute 2. The highest level of resistance against which a participant can extend their fingers twice in one minute (level 0: unable to perform, level 1: the lightest band, level 5: the strongest resistance band)

Secondary

MeasureTime frame
1. The Modified Box and Block Test (mBBT) will be used for it is similar to the task trained in this study (mean time 15 minutes). The MBBT is a performance-based measurement of unilateral gross manual dexterity. Participants sit on a dining-type chair at a table in front of a divided box. They are asked to pick up an object, between the tip of the index finger and tip of the thumb of the paretic hand and release this into the other side of the box. They are asked to repeat this task as many times as possible in 60 seconds. The test is undertaken three times and each time a different object is used. The objects are: a tennis ball; a 2.5 cm cube; and a 5 cm cube. Five minutes rest will be allowed before changing objects. 2. Upper limb strength elbow flexion/extension and hand muscles with a Myometer (mean time 10 minutes). Measuring grip strength is considered a sensitive method of charting intrinsic neurological recovery and functional recovery. Force values will be obtained during three trials, with the greatest value obtained used for data analysis. Participants will be seated on a dining type chair at a table. They will grip the handle of the myometer and then squeeze it (hand grip strength). Then pinch a specific part of the handle and squeeze (hand grip strength). The upper limb positions for all measurements follow standardized procedures (Fasoli, Trombly et al. 2002). The myometer will be set to ?zero? after the subject is positioned with their hand/digits around the bars at rest. Instruction will be ?squeeze as hard as you can?. 3. Excitability of the corticospinal pathways as assessed by Motor Evoked Potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) (mean time 40 minutes). Single pulse of TMS, using standard figure of eight coil, will be given over the hand and arm areas of primary motor cortex of the stroke and non-stroke hemisphere. MEP data will be recorded and analysed using Signal software. EMG reco

Countries

United Kingdom

Outcome results

None listed

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