Effectiveness of Paretic Lower Limb Loading During Over-ground Training Among Stroke Survivors

NCT05097391 | Completed DMC

• 1 other identifier: SPS/18/MPT/00033
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Post-stroke gait deviations contribute to significant functional disability, impaired walking ability and poor quality of life. Prior studies suggest that gait training with paretic lower limb loading may improve gait parameters and walking ability in post-stroke. However, most gait training methods used in these studies are not readily available, and studies using cheaper methods are limited.

Conditions

Stroke; Hemiparesis;Poststroke/CVA

Keywords

Lower limb loading; Over-ground training; Spatiotemporal gait parameters; Gait symmetry parameters; Motor function; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• Spatial gait parameters and symmetry

  Each participant will perform three trials of walking and the spatial gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in centimeters (cm) using measuring tape each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step length, stride length, foot angle, and stride width.

  Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 weeks

• Temporal gait parameters and symmetry

  Each participant will perform three trials of walking and the temporal gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in seconds (sec) using a stop watch each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step time, stride time, single limb support time, stance time, swing time, cadence, and gait speed.

  Change from baseline temporal gait parameters at 4 weeks; Change from baseline temporal gait parameters at 8 weeks

• The Lower limb motor functions

  The Motricity Index will be used to measure the lower limb functions of the participants. It is a reliable instrument for measuring the strength of the involved lower extremity when assessment following chronic stroke. Participant position: The test is administered in a sitting position. Patient will be asked to sit on a chair or on the edge of the bed. In the lower limb, the three movements to be tested are: hip flexion, knee extension, and dorsiflexion. The assessment will be carried out just before the over-ground training. All the data will be recorded. Thereafter, the total score of each participant will then be computed and documented. Scorings: 0 (No movement); 9 (Palpable contraction in muscle, but no movement); 14 (Visible movement, but not full range and not against gravity); 19 (Full range movement against gravity, but not resistance); 25 (Full movement against gravity, but weaker than the other side); 33 (Normal power).

  Change from baseline lower limb motor function at 4 weeks; Change from baseline lower limb motor function at 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training with lower limb loading (15-25 minutes)

Behavioral: Warm-up (5 minutes); Behavioral: Conventional physiotherapy exercise (15 minutes); Behavioral: Over-ground training with lower limb loading (15-25 minutes)

Control group

ACTIVE COMPARATOR

i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training WITHOUT lower limb loading (15-25 minutes)

Behavioral: Warm-up (5 minutes); Behavioral: Conventional physiotherapy exercise (15 minutes)

Interventions

Warm-up (5 minutes) BEHAVIORAL

Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.

Control group; Experimental group

Conventional physiotherapy exercise (15 minutes) BEHAVIORAL

The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.

Control group; Experimental group

Over-ground training with lower limb loading (15-25 minutes) BEHAVIORAL

Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded. The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes).

Experimental group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral ischemic or hemorrhagic stroke occurring at least 3 months before enrolment
• Male or female between the age of 20 and 70 years
• Having a Modified Rankin Scale (MRS) scores of 1, 2, or 3, and also able to walk at least 10 meters independently without an assistive device
• Ability to follow verbal instructions.

You may not qualify if:

• Cognitive impairments
• Visual impairments
• Musculoskeletal disorders that may affect gait such as arthritis
• Other neurological disorders such as Parkinson's disease, multiple sclerosis
• Cardio-respiratory conditions that may limit participation such as atelectasis
• Concurrent participation in other interventional clinical trials.

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead

Study Sites (1)

Muhammadu Abdullahi Wase Teaching Hospital

Kano, 700282, Nigeria

Location

Related Publications (1)

• Maje AU, Ibrahim AA. Effectiveness of an 8-week overground walking with paretic lower limb loading on spatiotemporal gait parameters and motor function among chronic stroke survivors: a protocol for randomised controlled trial. Trials. 2023 Feb 20;24(1):124. doi: 10.1186/s13063-022-07057-3.

  PMID: 36803399 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Warm-Up Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Abdulhamid U Maje, M.Sc.

  Muhammadu Abdullahi Wase Teaching Hospital, Kano State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Upon completion of all the baseline assessments, consenting participants will be stratified by MRS scores (i.e., 1, 2, and 3) and randomized into two groups: over-ground walking with lower limb loading or over-ground walking with lower limb non-loading in a 1:1 ratio by a third party not involved in other aspects of the study. The allocation of participants will be concealed using consecutively numbered, sealed, and opaque envelopes which will be prepared using a web-based randomization tool (available at https://www.sealedenvelope.com) with permuted block sizes of 6. All outcome assessors will be blinded to participants' group allocation. However, it will be impossible to blind the therapists and participants considering the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into either group A (experimental: over-ground walking with lower limb loading) or group B (control: over-ground walking without lower limb loading). Both groups will receive a warm-up consisting of passive stretching to hamstrings and calf muscles, and a range of motion exercise to the lower limbs for 5 min. Participants allocated to group A will receive conventional exercises (15 min) and then rest for 2 min, then proceeded with overground walking training with lower limb loading (15-25 min), and rest for 2 min. Those assigned to group B will receive the same conventional exercises (15 min) and overground walking but without lower limb loading. Treatment in both groups will be delivered thrice weekly for 8 weeks.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 28, 2021
• Study Start: August 2, 2021
• Primary Completion: February 25, 2023
• Study Completion: March 14, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)