The objective of the study is to assess whether 1) two of the questionnaires used are appropriate for this subgroup of stroke patients and 2) the combination of positioning of the hemiplegic arm with simultaneous application of electrical…
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Passive range of motion of the shoulder, elbow, forearm and wrist using a
masked fluid-filled goniometer.
2. Shoulder pain using a Dutch translation of the AbilityQ/ShoulderQ. This is a
questionnaire.
Secondary outcome
1. Impact of arm spasticity on arm activities in daily life using the Leeds Arm
Spasticity Impact Scale (LASIS). This is a questionnaire.
2. Spasticity/hypertonia of the shoulder internal rotators, elbow flexors and
extensors and the long finger flexors using the Modified Tardieu Scale.
3. The amount of use of spasticity and pain medication.
4. Selective movement ability of the hemiplegic arm using the 66-point arm
section of the Fugl-Meyer Assessment.
5. The degree of shoulder subluxation using a simple clinical scale.
Background summary
Each year more than 41.000 people are struck by a stroke in the Netherlands. In
more than 60% of the cases the hemiplegic arm remains without function. Disuse
of the arm makes it prone to the occurrence of contracture formation and
spasticity. This results in hemiplegic shoulder pain, motor impairments and
activity limitations (e.g. cleaning the arm, dressing). Available evidence
based single-modality treatments are not suitable for patients with poor motor
performance, and severely affected patients are underrepresented in the
research literature. Positioning procedures and electrical stimulation both
seem best suitable for severely affected stroke patients and combining these
treatment modalities may even be more efficacious. We hypothesize that the
electrical stimulation intensifies the effect of the positioning procedure,
resulting in (slowing down) contracture formation, less hemiplegic shoulder
pain, less restrictions in the stroke patient*s performance of arm activities
in daily life, decreased levels of spasticity and prevention of subluxation.
Study objective
The objective of the study is to assess whether 1) two of the questionnaires
used are appropriate for this subgroup of stroke patients and 2) the
combination of positioning of the hemiplegic arm with simultaneous application
of electrical stimulation affects the post/subacute stroke patient's arm joint
range of motion/degree of contracture, the occurrence of shoulder pain,
restrictions in performance of arm activities in daily life, the degree of
spasticity, the amount of intake of spasticity- and pain reducing medication,
the ability to make selective arm movements and the degree of shoulder
subluxation.
Study design
A multicenter single-blind (observer blind) randomized controlled trial.
Intervention
In addition to the care as usual, subjects allocated to the experimental group
will undergo 8 weeks of shoulder/arm positioning combined with therapeutic
electrical stimulation of the extensor muscles of the forearm and external
rotator muscles of the shoulder according to a well-defined (positioning)
procedure. The positioning procedure will be prescribed for 2 times a day for
45 minutes on working days (5 days a week), totalling up to 7.5 hours a week
and 60 hours during the 8 weeks of participation. During the 8 weeks of
participation, electrical stimulation time will gradually be increased from 2
times 10 minutes a day to 2 times 45 minutes a day after 2 weeks onto the end
of the treatment period. In addition to the usual care, subjects allocated to
the control group will the same frequency/intensity of shoulder/arm positioning
at about 50% of their maximum range of shoulder abduction. In this position,
the extensors of the forearm will be given a low-intensity conventional
transcutaneous electrical nerve stimulation (TENS) application.
Study burden and risks
During this trial, all participating patients will receive care as usual as
prescribed by their physiatrist. In addition the experimental and control
treatments are given, implying increased intensity of attention and/or
*training* for the involved upper limb. Because a sham treatment is given to
the control group we expect a difference between the two groups in favor of the
experimental group. A sham treatment is necessary to be able to evaluate the
effectiveness of the experimental treatment procedure. Both interventions are
well tolerated, are easily added to the usual rehabilitation programme and
therefore the burden of participation is minimal. The risks associated with
electrical stimulation are minimal. The application of electrical stimulation
can cause red coloration of the skin under the electrodes after use, but this
is usually gone within the hour after cessation of the stimulation. Some people
are allergic to the gel-elektrodes, but this rare reaction can be overcome by
using hypo-allergenic (allergy-neutral) elektrodes. In case of overdosage, skin
irritation can occur. This however is prevented by administering the electrical
stimulation with a minimum of 4 hours between each treatment session and
carefully checking the skin before and after each session.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
1. A first ever or recurrent stroke except subarachnoid hemorrhages,
2. Age above 18,
3. Between 2 and 8 weeks post-stroke,
4. An apparent paralysis / severe paresis of the involved upper limb.
Exclusion criteria
1. Any of the following contra indications for electrical stimulation: metal implants in the involved arm or shoulder, cardiac pacemaker, thrombosis, (thrombo)phlebitis, cancerous lesions, skin infections on forearm or shoulder blade, epileptic seizures six months previous to and/or since the stroke, pregnancy and myasthenia gravis/myotonia,
2. Pre-existent impairments of the affected arm (e.g. peripheral neuropathy, frozen shoulder),
3. The ability to make selective movements of the hemiplegic arm (more than 18 points on the shoulder-and elbow sections of the Fugl-Meyer Assessment arm score),
4. Severe cognitive deficits and/or severe language comprehension difficulties (more than one of four questions wrong on the verbal items of the AbilityQ),
5. Severe neglect (a difference of more than three on the letter cancellation test),
6. Severe loss of pain sensation. This criterium is tested by administering electrical stimulation to the extensor muscles of the forearm arm of the subject. If a patient shows a good motor response during stimulation, but does not feel the stimulation, he/she is excluded if (any) skin irritation occurs after a test-session of 10 minutes using the parameters of the experimental procedure. Patients with severe loss of pain sensation who tolerate the test session well will, for extra safety purposes, receive checks after each electrical stimulation session during participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22402.042.08 |