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Addition of Trunk Restraint to Home-Based Modified Constraint- Induced Movement Therapy after Stroke

Addition of Trunk Restraint to Home-Based Modified Constraint- Induced Movement Therapy after Stroke: A randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000698077
Enrollment
22
Registered
2010-08-24
Start date
2010-02-27
Completion date
2010-11-20
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

Studies which evaluated the effects of trunk restraint demonstrated that the hemiplegics who were trained with trunk restraint, demonstrated better performance in the tasks of reaching and grasping, with smaller displacements of the trunk, greater extension of the elbow, and better coordination between the joints than those who were trained without trunk restraint. Therefore, the aim of this study was to combine trunk restraint with modified CIMT (three hours of intensive training with a transfer package, shaping and task practice with restrictions of the less affected upper extremity of about 90% of the awake hours, during 14 days). The training protocol will be home-based to improve the transfer package. Therefore the specific research questions were: 1.Are two weeks of trunk restraint, plus modified home-based CIMT more effective than home-based modified CIMT alone in improving the amount and quality of the upper limb use and range of movement, smoothness, jerkiness, movement unity and velocity in the kinematics of reaching in chronic hemiplegics? 2.Are these gains maintained one and three months after the intervention has ceased?

Interventions

The experimental group will undertake modified Constraint-induced movement therapy (CIMT) and trunk restraint during two weeks of intensive training, five times a week, three hours daily. They will be required to use a glove which will restrict their less affected wrist and fingers by 90% of the time they are awake during the 14 days. The trunk restraint will be performed by an eight-shape clavicle immobilizer, with a seat belt strap with a buckle that fits to the size of the trunk of each indiv

The experimental group will undertake modified Constraint-induced movement therapy (CIMT) and trunk restraint during two weeks of intensive training, five times a week, three hours daily. They will be required to use a glove which will restrict their less affected wrist and fingers by 90% of the time they are awake during the 14 days. The trunk restraint will be performed by an eight-shape clavicle immobilizer, with a seat belt strap with a buckle that fits to the size of the trunk of each individual. This restraint will not permit upper trunk movements. Training will be performed by 30 minutes of the transfer package exposure and application of the items of the Motor Activity Logo (MAL) (30 or 15 items daily alternately ). This will be followed by two hours and 30 minutes of four shaping tasks, which may vary, depending upon the needs of each individual. The task practice of making a snack, will be the same for all individuals. Between each exercise, individuals will be allowed to rest for at least 30 seconds. Individual adjustments will be made for better adaptation and the training will be supervised by a trained physiotherapist. Blood pressure measurements will be obtained before and after the intervention and their heart rate will be continuously monitored by a Polar heart rate monitor.

Sponsors

Universidade Federal de Minas Gerais
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Stroke survivors will be included if they are over 21 years of age; are within more than six months of their stroke; show inability to use the upper limb (assessed by 2.5 to zero (0) on the Motor Activity Log-Brazil); have a range of motion of at least 45 degrees of shoulder flexion and abduction, 20 degrees of elbow extension, 10 degrees of wrist extension and greater than zero degree in the metacarpophalangeal joints, as confirmed by goniometric active measures; are able to stand for two minutes (with support of their upper limbs, if necessary), can move safely and independently (e.g., in the use of the toilet); can understand and follow the instructions, as determined by Mini-mental state examination (Brucki et al., 2003); have shoulder pain less than three (mild pain) on the Shoulder Q scores (Turner-Stokes and Jackson, 2006), and report enough visual acuity with or without corrections.

Exclusion criteria

Individuals with bilateral hemiplegia or other disabling neurological or musculoskeletal condition and who were submitted to the application of botulin toxin in less than three months (Blanton et al., 2006) will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026