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A pilot study to evaluate an intensive upper limb rehabilitation program after stroke

A pilot study investigating whether adults with stroke experience greater dexterity after using a Saebo splint in addition to their usual rehabilitation program compared to usual rehabilitation program alone.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000695808
Acronym
Nil.
Enrollment
9
Registered
2012-06-29
Start date
2011-09-29
Completion date
2012-05-09
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This project aims to develop and test the feasibility of a client­centred intervention for improving dexterity for people with stroke. Upper limb hemiplegia is common after stroke, and such people typically achieve lower levels of functional recovery. Many individuals suffering from hemiplegia after stroke exhibit some shoulder and elbow movement but little or no hand function, preventing them from participating in Constraint­ Induced Movement Therapy (CIMT). Using newer technologies such as a mechanical orthoses offers promise for stroke survivors with hemiplegia. However, no direct evidence exists for optimum wearing regimes, training protocols and timing of therapy. This study will therefore make a significant contribution to healthcare decision making. Participants in the 'treatment' group will be recruited from the Prince of wales in­patient hospital service and will receive an 8­-week intervention which will include intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task ­specific home exercise program using a hand splint. Participants in the 'control group' will be recruited from the same centre and will receive usual rehabilitation. Outcomes will be assessed at baseline, post­ intervention, and at 3 months following the conclusion of intervention and will include assessment of range of movement, dexterity, functional task performance, and quality of life.

Interventions

Use of a specific mechanical dynamic orthosis plus Occupational Therapy training (intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task­-specific home exercise program using the mechanical dynamic orthosis). The mechanical dynamic orthosis (Saebo splint) is worn on the hemiplegic arm only, and may be used up to twice daily (5 x per week) for a maximum session length of 60 minutes for 8 weeks. All sessions are administered by an occup

Use of a specific mechanical dynamic orthosis plus Occupational Therapy training (intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task­-specific home exercise program using the mechanical dynamic orthosis). The mechanical dynamic orthosis (Saebo splint) is worn on the hemiplegic arm only, and may be used up to twice daily (5 x per week) for a maximum session length of 60 minutes for 8 weeks. All sessions are administered by an occupational therapist within the hospital clinic environment.

Sponsors

Associate Professor Natasha Lannin
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. 18 years of age or older (adult), 2. diagnosis of stroke , 3. Upper limb hemiplegia (score of < 6 on 6 items 6 and/or 7 of the motor Assessment scale [16NL]Alert and oriented to person and place with the ability to complete at a minimum a one step verbal command, 4. Score of 21 or greater on the Mini­ mental State Examination. 5. Adequate English to communicate with the therapist/participate in a rehabilitation program. 6. Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension. 7. Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests

Exclusion criteria

1. Medically unsuitable for rehabilitation intervention, for example, inpatients who have been diagnosed as palliative. 2. Using the affected hand and arm, able to volitionally grasp and release a tennis ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more. 3. Complete flaccidity in the affected upper limb and hand 4. Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis. 5. History of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy. 6. Moderate to severe oedema

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026