Clinical trial NCT05365945: Trunk Stabilization Exercises Affect the Activity of the Upper Limb
Official title: The Use of Armeo®Spring Device to Assess the Effect of Trunk Stabilization Exercises on the Functional Capabilities of the Upper Limb - an Observational Study of Patients After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Armeo®Spring device,
ischemic stroke,
upper limb,
motor coordination,
trunk stabilization exercises,
NDT Bobath concept
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial was a randomized, double-blinded study, 10 days duration. The patients were divided into two groups: study and control and were subjected to different therapies (independent variables). The study group consisted of 30 people. Their physiotherapy was based on exercises that heavily employed the core muscles to equalize tension and strength, according to the NDT Bobath concept. The control group also consisted of 30 patients. They underwent classical neurological rehabilitation. All patients were examined twice. The first time after admission to the Rehabilitation Clinic, and the second time after 10 days of therapy. Assessment games were used for the study, which is the software of the Armeo®Spring device and proprietary tests, "wall" and "abacus" (dependent variables).
Primary purpose: TREATMENT

Brief summary: The aim of the study was to analyze the effect of trunk stabilization exercises on coordinated movement of the affected upper limb in patients after stroke, using the Armoe®Spring device and the "wall" and "abacus" functional tests. The study group had physiotherapy based on the NDT Bobath concept and the control group used classic exercises.

Detailed description: Almost half of the stroke patients report impaired function of the upper limb and hand. Stability of the trunk is required for the proper movement of the body, including the legs and arms. The aim of the study was to analyze the effect of trunk stabilization exercises on coordinated movement of the affected upper limb in patients after stroke, using the Armoe®Spring device and the "wall" and "abacus" functional tests. Material and method: this is a randomized, double-blinded study. The research was carried out in the Rehabilitation Clinic on a group of 60 stroke patients who were randomly assigned to groups differing in the rehabilitation program. The study group had physiotherapy based on the NDT Bobath concept and the control group used classic exercises. The importance of the trunk for upper limb coordination was assessed on the Armeo®Spring device using three evaluation programs: "perpendicular hunting"; "horizontal hunting"; "reaction time" and two proprietary tests: "wall" and "abacus".

Eligibility criteria: Inclusion Criteria: 1) patients 5 to 7 weeks after ischemic stroke; 2) patients with hemiparesis after stroke; 3) subjects with poor trunk control; 4) subjects who were in a functional state allowing movements of the upper extremity; 5) muscle tension that allows movement; 6) no severe deficits in communication, memory, or understanding what can impede proper measurement performance;

Exclusion Criteria: 1) lack of possibility to adjust the orthosis to the patient's treated limb, 2) bone instability (non-fused fractures, advanced osteoporosis), 3) permanent contracture of the treated limb, 4) open skin lesions in the area of the treated upper limb, 5) sensory deficits, disturbances, 6) shoulder subluxation or pain 7) increased spasticity, 8) increased involuntary movements, e.g. ataxia, dyskinesia, myoclonic seizures, 9) unstable life functions: contraindications related to the respiratory system or the cardiovascular system (instability or the need to use supportive devices), 10) the need for long-term intravenous therapy, 11) postural instability, 12) contraindication to a sitting position, 13) confused or uncooperative patients, 14) severe cognitive impairment, 15) patients requiring isolation due to infections, 16) severe vision problems (the patient is not in the ability to observe the elements displayed on the computer screen), 17) epilepsy.

Primary outcomes:
measure: Reaction time - time [s]
timeFrame: up to 10 days
measure: "Vertical Fishing"
timeFrame: up to 10 days
measure: "Horizontal Fishing "
timeFrame: up to 10 days
measure: "WALL" test
timeFrame: up to 10 days
measure: "ABACUS" test
timeFrame: up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Masovian District
Study officials:
affiliation: Military Institute of Medicine (Poland), Rehabilitation Clinic
name: Anna Olczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: