Observation with Intent to Imitate (OTI) combined with Motor Practice (MP) to enhance upper limb recovery early after stroke

Observation with Intent to Imitate (OTI) combined with Motor Practice (MP) to enhance upper limb recovery early after stroke: proof-of-concept trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51553998

Enrollment

Registered

2009-01-30

Start date

2009-01-12

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Upper limb paralysis after stroke Musculoskeletal Diseases

Interventions

The participants will be randomly allocated to the control and intervention groups in 1:1 ratio. The control intervention will be routine conventional therapy as provided in the clinical centre. All

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (both males and females, 18 years +) between 3 and 31 days after stroke with an intact pre-motor area (location of mirror neurons) as confirmed by routine clinical imaging 2. A substantially paretic upper limb as measured by a grip force of between 15% and 65% of that of the non-paretic upper limb

Exclusion criteria

Exclusion criteria: Unable to imitate action with their non-paretic limb (i.e. severe visual, communication or cognitive deficits precluding participation in OTI+MP). This will be assessed by the research therapist sitting along side the potential participant. The research therapist will perform 5 actions and the potential participant will be asked to observe and then perform the actions. This assessment will be videoed and saved onto a computer. The accuracy of observed activity will be assessed by 2 independent assessors from the video film using a three point scale used by Decety and colleagues: 2 = correctly reproduced action; 1 = incorrectly reproduced action; 0 = action not produced. Those scoring 8/10 or above will be considered to have the ability to imitate.

Design outcomes

Primary

Measure	Time frame
The following will be assessed at baseline and one/two days after the 15th intervention session: 1. Ability to produce voluntary contraction of paretic muscle, as measured by the Motricity Index ? arm section. The rationale for this measure is that OTI therapy is primarily directed at improving the ability to voluntarily contract paretic muscle after stroke. The Motricity Index is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke. 2. Ability to produce force in paretic muscle, as measured by torque about the elbow joint during isometric flexion concentric contraction using a digital myometer and maximum pinch and grip force during isometric concentric contraction using a digital pinch/grip analyser (MIE Medical Research Ltd, UK). 3. Ability to use the paretic upper limb in functional activity as measured by the Action Research Arm Test (ARAT). This is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. It has good validity and reliability and is widely used in clinical research. 4. Adverse event monitoring and recording. There is a small risk that for some people the therapy might lead to an 'overuse' syndrome which presents as pain in the arm and/or hand. We will monitor this by checking for participant report of upper limb pain, either verbal or behavioural (e.g., grimacing, postural guarding), and for decrease in Motricity Index upper limb score of at least two measurement levels.	—

Measure

Time frame

The following will be assessed at baseline and one/two days after the 15th intervention session: 1. Ability to produce voluntary contraction of paretic muscle, as measured by the Motricity Index ? arm section. The rationale for this measure is that OTI therapy is primarily directed at improving the ability to voluntarily contract paretic muscle after stroke. The Motricity Index is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke. 2. Ability to produce force in paretic muscle, as measured by torque about the elbow joint during isometric flexion concentric contraction using a digital myometer and maximum pinch and grip force during isometric concentric contraction using a digital pinch/grip analyser (MIE Medical Research Ltd, UK). 3. Ability to use the paretic upper limb in functional activity as measured by the Action Research Arm Test (ARAT). This is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. It has good validity and reliability and is widely used in clinical research. 4. Adverse event monitoring and recording. There is a small risk that for some people the therapy might lead to an 'overuse' syndrome which presents as pain in the arm and/or hand. We will monitor this by checking for participant report of upper limb pain, either verbal or behavioural (e.g., grimacing, postural guarding), and for decrease in Motricity Index upper limb score of at least two measurement levels.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

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