StrokeNCT05365945
Trunk Stabilization Exercises Affect the Activity of the Upper Limb
A study testing NDT Bobath therapy and The classic exercises. in people with Stroke, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- NDT Bobath therapy and The classic exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 2 Mar 2020to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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".
- Conditions
- Stroke
- Being tested
- NDT Bobath therapy, The classic exercises.
- Keywords
- Armeo®Spring device,, ischemic stroke,, upper limb,, motor coordination,, trunk stabilization exercises,, NDT Bobath concept
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDT Bobath therapyOther
Their physiotherapy was based on exercises that heavily employed the core muscles to equalize tension and strength, according to the NDT Bobath concept. The duration of the treatment session for each patient in both groups was 120 minutes.
The classic exercises.Other
They underwent classical neurological rehabilitation. such as passive exercises, but also an approximation. In addition, the patients performed self-assisted exercises on a manual rotor, and in order to relieve the directly affected limb, the patients exercised in a suspension system. As the physiotherapy progressed, the patients performed active exercises, and then active exercises with resistance, e.g. using the Thera Band. Patients also exercised their balance with the use of large gymnastic balls or sensor pads. A large part of the physiotherapy was locomotion training and gait re-education.
The duration of the treatment session for each patient in both groups was 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| The study group | Experimental | Not described Receives: Other: NDT Bobath therapy |
| The control group | Active comparator | Not described Receives: Other: The classic exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time - time [s]
The patient moved his hand in the frontal plane to catch the fly. The rules of the game are the same as in the previous games, with the difference that each time the patient has to return to the center of the screen, to the shelf, and should remain on the shelf until another object appears on the screen. As in the previous games, the study on level I, working area 30 x 26 cm, to catch 20 objects.
Measured: up to 10 days
"Vertical Fishing"
The patient's task is to catch a ladybug. In this evaluation game, the patient has to move his hand in a vertical plane. When it touches a ladybug, the ladybug disappears and a new one appears elsewhere. If the patient does not touch the ladybug within the allotted time, the ladybug also disappears and another reappears elsewhere. The patients were tested on the 1st level of difficulty, which means that the field of work was 40 x 30 cm and they had 12 objects to catch.
Measured: up to 10 days
"Horizontal Fishing "
As in the previous game, the patient's task is to catch the red ball. In this evaluation game, the patient has to move his upper limb horizontally. The rules for the appearance and disappearance of an item are the same as in the previous game.
The patients were tested on the 1st level of difficulty, which means that the field of work was 40 x 30 cm and they had 12 objects to catch.
Measured: up to 10 days
"WALL" test
It consists in lifting the upper limb on one's own and moving the limb along the wall as high as possible. Patients performed it sitting straight with their knees pressed against the wall. Patients were scored according to the following schedule:
0- the patient does not raise the upper limb
- the patient raises the upper limb to shoulder height
- the patient raises the upper limb to the height of the head
- the patient raises the upper limb above the head The purpose of the test was to assess the functional capabilities in the shoulder joint of the affected upper limb. This test examined whether the patient could overcome the force of gravity.
Measured: up to 10 days
"ABACUS" test
It was performed on classic mathematical abacuses. The patient's task was to move the beads from one edge of the abacus to the other with two fingers (index and thumb) of the affected upper limb. The result of the test was the number of beads moved in 30 seconds.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start2 Mar 2020
- Primary completion12 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Olczak, Military Institute od Medicine National Research Institute
- Investigators
- Anna Olczak, PhD, Principal investigator, Military Institute of Medicine (Poland), Rehabilitation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365945
- Sponsor's protocol ID
- 4/KRN/2020
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05365945
- Acronym / sponsor ID
- 4/KRN/2020
- Conditions
- Stroke
- Keywords
- Armeo®Spring device,, ischemic stroke,, upper limb,, motor coordination,, trunk stabilization exercises,, NDT Bobath concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| The study group | Experimental | Other: NDT Bobath therapy |
| The control group | Active comparator | Other: The classic exercises. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDT Bobath therapyTheir physiotherapy was based on exercises that heavily employed the core muscles to equalize tension and strength, according to the NDT Bobath concept. The duration of the treatment session for each patient in both groups was 120 minutes. | Other | The study group |
| The classic exercises.They underwent classical neurological rehabilitation. such as passive exercises, but also an approximation. In addition, the patients performed self-assisted exercises on a manual rotor, and in order to relieve the directly affected limb, the patients exercised in a suspension system. As the physiotherapy progressed, the patients performed active exercises, and then active exercises with resistance, e.g. using the Thera Band. Patients also exercised their balance with the use of large gymnastic balls or sensor pads. A large part of the physiotherapy was locomotion training and gait re-education. The duration of the treatment session for each patient in both groups was 120 minutes. | Other | The control group |
Primary outcome
Reaction time - time [s]
Time frame: up to 10 days
The patient moved his hand in the frontal plane to catch the fly. The rules of the game are the same as in the previous games, with the difference that each time the patient has to return to the center of the screen, to the shelf, and should remain on the shelf until another object appears on the screen. As in the previous games, the study on level I, working area 30 x 26 cm, to catch 20 objects.
"Vertical Fishing"
Time frame: up to 10 days
The patient's task is to catch a ladybug. In this evaluation game, the patient has to move his hand in a vertical plane. When it touches a ladybug, the ladybug disappears and a new one appears elsewhere. If the patient does not touch the ladybug within the allotted time, the ladybug also disappears and another reappears elsewhere. The patients were tested on the 1st level of difficulty, which means that the field of work was 40 x 30 cm and they had 12 objects to catch.
"Horizontal Fishing "
Time frame: up to 10 days
As in the previous game, the patient's task is to catch the red ball. In this evaluation game, the patient has to move his upper limb horizontally. The rules for the appearance and disappearance of an item are the same as in the previous game. The patients were tested on the 1st level of difficulty, which means that the field of work was 40 x 30 cm and they had 12 objects to catch.
"WALL" test
Time frame: up to 10 days
It consists in lifting the upper limb on one's own and moving the limb along the wall as high as possible. Patients performed it sitting straight with their knees pressed against the wall. Patients were scored according to the following schedule: 0- the patient does not raise the upper limb 1. the patient raises the upper limb to shoulder height 2. the patient raises the upper limb to the height of the head 3. the patient raises the upper limb above the head The purpose of the test was to assess the functional capabilities in the shoulder joint of the affected upper limb. This test examined whether the patient could overcome the force of gravity.
"ABACUS" test
Time frame: up to 10 days
It was performed on classic mathematical abacuses. The patient's task was to move the beads from one edge of the abacus to the other with two fingers (index and thumb) of the affected upper limb. The result of the test was the number of beads moved in 30 seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Olczak, PhD principal investigator
Military Institute of Medicine (Poland), Rehabilitation Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDT Bobath therapy and The classic exercises. in people with Stroke, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time - time [s] (time frame: up to 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.