Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03058770 |
| Other study ID # |
H14831 09435066 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2017 |
| Est. completion date |
March 31, 2018 |
Study information
| Verified date |
May 2024 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A prospective, randomized double-blind clinical trial will be conducted to determine the
effect of a sensorimotor retraining program on the sensory and functional recovery of the
paretic lower limb of subjects with chronic sequelae from stroke.
Description:
Somatosensory deficits are a common symptom after stroke, affecting a high percentage of
survivors (50-80%). These impairments have a long-term influence on somatosensory capacity,
motor ability and functional performance. Although several authors have studied the effect of
sensorimotor retraining on recovery of the paretic upper limb, a few have investigated its
effect on the paretic lower limb. Furthermore, most of them have done so in the acute and
subacute phases after stroke. Thus, in this field there is a lack of studies of high
methodological quality that provide effective physiotherapeutic interventions, especially in
chronic stroke.
On the other hand, the importance of motor recovery of the paretic lower limb in order to
achieve a better balance, gait and independence in the activities of daily living is well
established. In this regard, sensory loss in the feet may difficult effective motor function
recovery due to its impacts upon ambulatory activity. After stroke, sensory dysfunction in
the lower limb has been related to reductions in static and dynamic balance as well as in
gait speed and symmetry. Therefore, successful recovery of sensory function after stroke may
allow for the appropriate integration of sensory inputs in order to maintain balance and
adapt to changing environmental demands during gait.
Since the current evidence indicates that there may be recovery of sensory loss during the
chronic phase of stroke, the present study aims to evaluate the effect of a sensorimotor
retraining program on sensory and functional recovery of the paretic lower limb in chronic
stroke. The investigators hypothesized that stroke survivors receiving the somatosensory
training program would demonstrate significantly greater improvement in sensation, static and
dynamic balance and gait pattern in comparison with the control intervention.
To cope with the objective of the study, a prospective randomized double-blind clinical trial
will be conducted. By means of advertisements in supporting groups, rehabilitation facilities
and the external consultations of various hospitals, subjects who meet the inclusion criteria
will be recruited. After screening and giving signed consent, participants will be randomly
allocated to the intervention group or the control group. In addition to the usual physical
activity, participants will complete fifteen 40-minute sessions of sensorimotor retraining
(intervention group) or of Jacobson relaxation (control group) over a 5-week period.
Participants will be assessed prior to treatment and on completion of treatment.
