Trunk Stabilization Exercises Affect the Activity of the Upper Limb

NCT05365945 | Completed

• 1 other identifier: 4/KRN/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Armeo®Spring device,; ischemic stroke,; upper limb,; motor coordination,; trunk stabilization exercises,; NDT Bobath concept

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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 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.

  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.

  up to 10 days

Study Arms (2)

The study group

EXPERIMENTAL

Other: NDT Bobath therapy

The control group

ACTIVE COMPARATOR

Other: The classic exercises.

Interventions

NDT Bobath therapy 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 study group

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.

The control group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian District, 04-141, Poland

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Olczak, PhD

  Military Institute of Medicine (Poland), Rehabilitation Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; Senior Specjalit of the Rehabilitation Clinc

Model Details: 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).

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 9, 2022
• Study Start: March 2, 2020
• Primary Completion: March 12, 2020
• Study Completion: March 15, 2020
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)