Trunk Stabilization Exercises Affect the Activity of the Upper Limb

NCT ID: NCT05365945

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-03-15

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".

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

The study group

Group Type: EXPERIMENTAL

NDT Bobath therapy

Intervention Type: OTHER

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 control group

Group Type: ACTIVE_COMPARATOR

The classic exercises.

Intervention Type: 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.

Interventions

NDT Bobath therapy

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Anna Olczak

PhD; Senior Specjalit of the Rehabilitation Clinc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Olczak, PhD

Role: PRINCIPAL_INVESTIGATOR

Military Institute of Medicine (Poland), Rehabilitation Clinic

Locations

Military Institute of Medicine

Warsaw, Masovian District, Poland

Countries

Poland

Other Identifiers

4/KRN/2020

Identifier Type: -

Identifier Source: org_study_id