Effects of Body Weight Supported Treadmill Training along with Electrical Stimulation on Functional Ambulation, Pain and Quality Of Life in Patients with Incomplete Traumatic Spinal Cord Injury

Assessment of the impact of BWSTT in combination with electrical stimulation on functional ambulation in patients with incomplete traumatic spinal cord injuries.

Three arm parallel group, randomized trial with blinded patients and data analyst. Simple randomization and concealment of the randomization sequence was performed using R software.

This single center study includes 81 patients having incomplete traumatic spinal cord injuries. The patients will be randomly divided into 3 groups, namely Group I (BWSTT + ES + conventional physical therapy), Group II (BWSTT + conventional physical therapy), and Group III (conventional physical therapy only). Patients will be assessed in terms of the study outcomes before treatment and 6 ,12 week after intervention.

Inclusion criteria Patients aged between 16-55 years Both male and female patients Patients with incomplete traumatic SCIs (ASIA scale B, C, D) Patients with stable spines and in the sub-acute rehabilitation phase Patients with mild neuropathic pain (1-3 on Visual Analogue Scale) Exclusion criteria Patients in acute phase of rehabilitation Patients with pressure sores, infections or other complications Patients with visual impairments that may impact participation in rehabilitation

Intervention group 1: Participants in this group will receive body weight supported treadmill training along with electrical stimulation and conventional physical therapy. Intervention group 2: Participants in this group will receive body weight supported treadmill training and conventional physical therapy Control group: Participants in this group will receive conventional physical therapy only.

Functional ambulation, neuropathic pain level and inflammatory pain markers (CRP, IL-6, IL-2), quality of life and activities of daily living.

The patients were randomly assigned to three groups. The randomization process for assigning participants to these groups was performed using R software, ensuring a randomized distribution of patients among the three treatment groups. Group I: Participants in this group were designated to receive Body Weight Supported Treadmill Training (BWSTT) along with electrical stimulation (ES) in addition to conventional physical therapy. Group II: Participants in this group were assigned to receive BWSTT and conventional physical therapy. Group III: Participants in this group were assigned to receive conventional physical therapy only.

A double-blind design was implemented to minimize bias and ensure the integrity of the research. The blinding process began with the invitation and recruitment of patients to participate in the study. During this stage, the patients were unaware of the specific treatment group they would be assigned to. The blinding will be maintained by not disclosing any information regarding the intervention groups. Following the recruitment phase, the patients were divided into their respective intervention groups, namely Group I (BWSTT + ES + conventional physical therapy), Group II (BWSTT + conventional physical therapy), and Group III (conventional physical therapy only). The allocation of patients into these groups was carried out by an independent individual not involved in the direct treatment or assessment of participants. This individual was also blinded to the nature of the interventions. The data analyst responsible for analyzing the collected data will remain unaware of the participants' group assignments and the specific treatments received by each group. This individual will be conducting the analysis without any knowledge that could potentially bias the interpretation of the results. By employing a double-blind approach, both the patients and the data analyst were kept unaware of the treatment allocations. This blinding methodology prevents potential biases from influencing the results, thereby enhancing the scientific validity and reliability of our study.

Ethical concerns